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| NDC | 37945-870-40, 37945-874-11, 37945-876-91, 37945-894-05 |
| Set ID | 79f8fc90-2447-4224-ac79-1645d1c82d4f |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Bio-Medical & Pharmaceutical Manufacturing Corporation |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART333D |
- THIS SYSTEM CONTAINS:
- DRUG FACTS
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- KEEP OUT OF REACH OF CHILDREN
-
Directions
Acne Treatment Wash
- At least once each day, dispense a small amount of cleanser onto an exfoliating pad or cloth.
- Add a small amount of water and work into a lather on the face using small circular motions avoiding the eyes.
- Repeat after perspiration or makeup use.
- If dryness occurs, reduce frequency to once each day.
Acne Treatment Gel
- Each night, dispense a small amount of gel onto the fingertips.
- Spread gel sparingly on the face and other affected areas using small circular motions avoiding the eyes.
- Repeat after perspiration or makeup use.
- If dryness occurs, reduce frequency to once each day.
- Sensitivity Test for a New User - Acne Treatment Gel
-
Inactive Ingredients
Acne Treatment Wash
Purified Water, Ammonium Lauryl Sulfate, Lauramidopropyl Betaine, Propylene Glycol, Hydroxypropyl Bis-Hydroxyethyldimonium Chloride, Triethanolamine, Hydroxypropylmethylcellulose, Magnesium Sulfate, 3-iodo-2-propynylbutylcarbamate, Diazolidinyl Urea, Peppermint Oil, Methylparaben, Propylparaben.
Acne Treatment Gel
Purified Water, Alcohol, Glycerin, Xanthan Gum, Polysorbate 20, Peppermint Oil, (.Alpha.-Tocopherol Acetate), Wheat Germ Oil, Glycolic Acid, Tert-Butyl Alcohol, Brucine Sulfate.
- Questions or Comments
- Kleer-Plex Advanced Acne SystemPrincipal Display PanelNDC# 37945-876-91
-
INGREDIENTS AND APPEARANCE
KLEER-PLEX ADVANCED ACNE CARE SYSTEM
salicylic acid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37945-876 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37945-876-91 1 in 1 KIT; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PUMP 118 mL Part 2 1 BOTTLE 236.558 mL Part 3 1 BOTTLE 30 mL Part 4 1 APPLICATOR 15 mL Part 1 of 4 KLEER-PLEX FOAMING ACNE CLARIFIER
salicylic acid liquidProduct Information Item Code (Source) NDC:37945-870 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE (UNII: 1EO3O1X7HG) TROLAMINE (UNII: 9O3K93S3TK) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM SULFATE (UNII: DE08037SAB) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) PEPPERMINT OIL (UNII: AV092KU4JH) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37945-870-40 1 in 1 BOX 1 118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 11/03/2014 Part 2 of 4 KLEER-PLEX PORE PURIFIER AND TONER
face and neck (excluding shaving preparations)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WITCH HAZEL (UNII: 101I4J0U34) INGR HORSE CHESTNUT (UNII: 3C18L6RJAZ) INGR WHITE OAK BARK (UNII: 93LP7Y8EGT) INGR ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) INGR CHASTE TREE (UNII: 433OSF3U8A) INGR GOLDENSEAL (UNII: ZW3Z11D0JV) INGR ALCOHOL (UNII: 3K9958V90M) INGR LAVENDER OIL (UNII: ZBP1YXW0H8) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR ETHYL LAUROYL ARGINATE HYDROCHLORIDE (UNII: XPD6ZY79TB) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR LEMON OIL, DISTILLED (UNII: ET5GD00TRP) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR 10-HYDROXYDECANOIC ACID (UNII: NP03XO416B) INGR SEBACIC ACID (UNII: 97AN39ICTC) INGR 1,10-DECANEDIOL (UNII: 5I577UDK52) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 236.558 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Part 3 of 4 KLEER-PLEX PENETRATING ACNE
salicylic acid gelProduct Information Item Code (Source) NDC:37945-874 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) POLYSORBATE 20 (UNII: 7T1F30V5YH) PEPPERMINT OIL (UNII: AV092KU4JH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WHEAT GERM OIL (UNII: 14C97E680P) GLYCOLIC ACID (UNII: 0WT12SX38S) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) BRUCINE SULFATE (UNII: KY7O12XPOQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37945-874-11 1 in 1 BOX 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 10/22/2014 Part 4 of 4 KLEER-PLEX TARGETED ACNE PEN
salicylic acid gelProduct Information Item Code (Source) NDC:37945-894 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) POLYSORBATE 20 (UNII: 7T1F30V5YH) PEPPERMINT OIL (UNII: AV092KU4JH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WHEAT GERM OIL (UNII: 14C97E680P) GLYCOLIC ACID (UNII: 0WT12SX38S) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) BRUCINE SULFATE (UNII: KY7O12XPOQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37945-894-05 1 in 1 BOX 1 15 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 OTC monograph final part333D 10/22/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 11/03/2014 Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356) Establishment Name Address ID/FEI Business Operations Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(37945-876, 37945-870, 37945-874, 37945-894)
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