- Active ingredients
- Purpose
- Uses
-
Warnings
For external use only. Flammable, keep away from fire or flame.
To reduce risk of fire; PREP CAREFULLY;
- solution contains alcohol and gives off flammable vapors
- avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
- do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)
- do not allow solution to pool
- remove wet materials from prep area
Allergy Alert: This product may cause a severe allergic reaction. Symptoms may include:
- wheezing/difficulty breathing
- shock
- facial swelling
- hives
- rash
If an allergic reaction occurs, stop use and seek medical help right away.
Do not use
- on patients with known allergies to chlorhexidine gluconate or any other ingredient in this product
- for lumbar puncture or in contact with the meninges
- on open skin wounds or as a general skin cleanser
When using this product
- keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.
- to avoid skin injury, care should be taken when removing drapes, tapes, etc...applied over film
-
Directions (follow all directions for use)
- use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
- discard the applicator after a singular use along with any portion of the solution not required to cover the prepped area. It is not necessary to use the entire amount available.
Getting Patient Ready for Solution:
- use in well-ventilated area
- do not microwave or heat the solution applicator
- apply to clean, completely dry, residue-free, intact skin
- when hair removal is necessary, use a surgical clipper on the morning of the surgery. If a wet shave is used, thoroughly remove all soap residues.
Activating the Applicator:
- remove applicator from package; do not touch sponge
- grasp product by wrapping hand and fingers around the labeled portion of the applicator. Place thumb on the lever.
- with sponge face parallel to the floor, snap level. Allow all fluid to flow into sponge.
When Applying Solution:
- completely wet the treatment area with antiseptic
- dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds
- moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes
- maximal treatment area for one applicator is approximately 13 in. x 13 in. (178.8 in 2).
- do not allow solution to pool; tuck prep towels to absorb solution, and then remove
- avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
- when prepping skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart until completely dry. Otherwise, skin may adhere to itself.
After Applying Solution:
- to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)
While Waiting for Solution to Completely Dry:
- do not drape or use ignition source (e.g., cautery, laser)
- check for pooled solution. Use sterile gauze to soak up pooled solution. Do not blot because it may remove solution from skin.
- remove wet materials from prep area. Replace if necessary.
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
-
Warnings
For external use only. Flammable, keep away from fire or flame.
To reduce risk of fire; PREP CAREFULLY;
- solution contains alcohol and gives off flammable vapors
- avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
- do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)
- do not allow solution to pool
- remove wet materials from prep area
Allergy Alert: This product may cause a severe allergic reaction. Symptoms may include:
- wheezing/difficulty breathing
- shock
- facial swelling
- hives
- rash
If an allergic reaction occurs, stop use and seek medical help right away.
Do not use
- on patients with known allergies to chlorhexidine gluconate or any other ingredient in this product
- for lumbar puncture or in contact with the meninges
- on open skin wounds or as a general skin cleanser
When using this product
- keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.
- to avoid skin injury, care should be taken when removing drapes, tapes, etc...applied over film
-
Directions (follow all directions for use)
- use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
- discard the applicator after a singular use along with any portion of the solution not required to cover the prepped area. It is not necessary to use the entire amount available.
Getting Patient Ready for Solution:
- use in well-ventilated area
- do not microwave or heat the solution applicator
- apply to clean, completely dry, residue-free, intact skin
- when hair removal is necessary, use a surgical clipper on the morning of the surgery. If a wet shave is used, thoroughly remove all soap residues.
Activating the Applicator:
- remove applicator from package; do not touch sponge
- with sponge face parallel to the floor, press the cap end of the applicator. Solution will begin to flow into the sponge.
- wait for fluid level to reach indicator line of applicator barrel
When Applying Solution:
- completely wet the treatment area with antiseptic
- dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds
- moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes
- maximal treatment area for one applicator is approximately 13 in. x 13 in. (178.8 in 2)
- do not allow solution to pool; tuck prep towels to absorb solution, and then remove
- avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
- when prepping skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart until completely dry. Otherwise, skin may adhere to itself.
After Applying Solution:
- to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)
- Other information
- Inactive ingredients
- Questions?
-
Principal Display Panel - 26mL Green Applicator Label
3M
NDC 17518-080-01
STERILE EO
SoluPrep™
Film-Forming Sterile Surgical Solution
chlorhexidine gluconate (2% w/v) and isopropyl alcohol (70% v/v)
REF 7130
Patient Preoperative Skin Preparation
for large prep areas below the neck
Sterile Solution
Applicator is sterile if package is intact
Brite Green
0.9 fl oz • 26 mL
Single Use
Only
PRESS CAP DOWN
BACK AND FORTH APPLICATION
External use only
Professional use only
Read Drug Facts Information before use
34-8721-0712-2
3M and SoluPrep are trademarks of 3M.
-
Principal Display Panel - 26mL Green Insert Label
3M
STERILE EO
NDC 17518-080-01
SoluPrep™
Film-Forming Sterile Surgical Solution
chlorhexidine gluconate (2% w/v) and isopropyl alcohol (70% v/v)
Patient Preoperative Skin Preparation
for large prep areas below the neck
Sterile Solution
Applicator is sterile if package is intact
Brite Green
SoluPrep™ Surgical Solution is a film-forming, sterile patient preoperative skin
preparation. Each unit dose applicator contains 0.9 fl oz (26 mL) of solution which covers
a 19.5 in. x 19.5 in. area (approximate from shoulder to groin in an average full size adult).
For procedures requiring less coverage, a smaller applicator is available (7133 - Tinted or
7134 - Clear). The smaller applicator size contains 0.36 fl oz (10.5 mL) of solution which
covers an approximate 13 in. x 13 in. area. Do not use more than required for the area.
3M recommends all users participate in product in-service training prior to use.
In-servicing is available on video, from your 3M site representative or at the 3M website
(www.3m.com).
SoluPrep™ Film-Forming Sterile Surgical Solution is an antimicrobial skin
preparation. It is recommended that the Prep remain on the skin after the procedure for
continued protection. The prep will gradually wear away. If however early removal is
desired, use 70% isopropyl alcohol. Place alcohol soaked gauze for approximately
40 seconds on the prepped area. Lightly rub gauze over area to remove prep.
REF 7130
0.9 fl oz • 26 mL
Made in U.S.A. by
3M Health Care
2510 Conway Ave.
St. Paul, MN 55144
1-800-228-3957
www.3m.com/Medical
Single Use Only
3M and SoluPrep are trademarks of 3M.
@ 2018, 3M. All rights reserved.
Not Made With Natural Rubber Latex
-
Principal Display Panel – 10.5 mL Applicator Labels
3M
NDC 17518-081-02
STERILE EO
SoluPrep™
Film-Forming Sterile Surgical Solution
chlorhexidine gluconate (2% w/v) and isopropyl alcohol (70% v/v)
REF 7134
Patient Preoperative Skin Preparation
for head, neck, and small prep areas
Sterile Solution
Applicator is sterile if package is intact
Clear
0.36 fl oz • 10.5 mL
Single Use Only
SNAP
BACK AND FORTH APPLICATOR
3M and
SoluPrep
are trademarks
of 3M.
External use only
Professional use only
Read Drug Facts Information before use
34-8721-0718-9
-
Principal Display Panel – 10.5mL Clear Insert Label
3M
STERILE EO
NDC 17518-081-02
SoluPrep™
Film Forming Sterile Solution
chlorhexidine gluconate (2% w/v) and isopropyl alcohol (70% v/v)
Patient Preoperative Skin Preparation
for head, neck, and small prep areas
Sterile Solution
Applicator is sterile if package is intact
Clear
Not Made With Natural Rubber Latex
Single Use Only
SoluPrep™ Surgical Solution is a film-forming, sterile
patient preoperative skin preparation. Each unit dose
applicator contains 0.36 fl oz (10.5 mL) of solution which
covers a 13 in. x 13 in. area.
3M recommends all users participate in product
in-service training prior to use. In-servicing is available
on video, from your 3M site representative or at the 3M
website (www.3m.com).
SoluPrep™ Film-Forming Sterile Surgical Solution is an
antimicrobial skin preparation. It is recommended that
the Prep remain on the skin after the procedure for
continued protection. The prep will gradually wear away.
If however early removal is desired, use 70% isopropyl
alcohol. Place alcohol soaked gauze for approximately 40
seconds on the prepped area. Lightly rub gauze over area
to remove prep.
REF 7134
0.36 fl oz • 10.5 mL
Made in U.S.A. by
3M Health Care
2510 Conway Ave.
St. Paul, MN 55144
1-800-228-3957
www.3m.com/Medical
3M and SoluPrep are trademarks of 3M.
@ 2018, 3M. All rights reserved.
34-8716-0123-2
-
INGREDIENTS AND APPEARANCE
3M SOLUPREP
chlorhexidine gluconate and isopropyl alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17518-080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L) Chlorhexidine Gluconate 20 mg in 1 mL Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength Trisodium Hedta (UNII: K3E0U7O8KI) Acetyltributyl Citrate (UNII: 0ZBX0N59RZ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17518-080-01 1 in 1 POUCH 10/08/2018 1 26 mL in 1 APPLICATOR; Type 0: Not a Combination Product 2 NDC:17518-080-02 1 in 1 POUCH 10/08/2018 2 10.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208288 10/08/2018 3M SOLUPREP
chlorhexidine gluconate and isopropyl alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17518-081 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L) Chlorhexidine Gluconate 20 mg in 1 mL Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength Trisodium Hedta MonoHydrate (UNII: 463A7RIB6K) Acetyltributyl Citrate (UNII: 0ZBX0N59RZ) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17518-081-02 1 in 1 POUCH 10/08/2018 1 10.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208288 10/08/2018 09/30/2020 Labeler - 3M Company (006173082) Establishment Name Address ID/FEI Business Operations 3M Company 830016148 ANALYSIS(17518-080, 17518-081)
