Procuretriple Antibiotic Triple Antibiotic (Bacitracin Zinc Neomycin Sulfate Polymyxin B) Ointment [Twin Med, Llc] -

PROCURETRIPLE ANTIBIOTIC TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B) OINTMENT [TWIN MED, LLC]
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NDC	55681-216-01
Set ID	71592776-407b-489c-8cdb-8c0573d844f8
Category	HUMAN OTC DRUG LABEL
Packager	TWIN MED, LLC
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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Active Ingredients(in each gram)

Bacitracin Zinc............400 units
Neomycin Sulfate 5mg (equivalent to 3.5 mg Neomycin)
Polymyxin B Sulfate ....5000 units
Purpose

First Aid Antibiotic
Uses
First aid to prevent infection in
- Minor cuts
- Scrapes
- Burns
Directions
- Clean the affected area
- Apply small amount of this product(an amount equal to the surface area of the tip of the finger on the area 1 to 3 times daily
- May be covered with a sterile bandage
Warnings
For External Use Only.
Do not use
- In the eyes
- If you are allergic to any of the ingredients
- Over large areas of the body
- Longer than 1 week unless directed by a doctor
- Ask a doctor before use in case of deep or puncture wounds, animal bites or serious burns
Stop use and ask a doctor if
- The condition persists or gets worse
- A rash or allergic reaction develops
Keep out of reach of children
- If swallowed, get medical help or contact a Poison Control Centre right away
Other information
- Store at controlled room temperature 15 o - 30 oC(59 o--86 o F)
- Avoid excessive heat and humidity
- Tamper Evident
- Do not use if packet is torn, cut or opened.
Inactive Ingredients

White Soft Paraffin
Principal Display Panel

INGREDIENTS AND APPEARANCE

PROCURETRIPLE ANTIBIOTIC TRIPLE ANTIBIOTIC
bacitracin zinc neomycin sulfate polymyxin b ointment

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 U in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 U in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55681-216-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product	09/22/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	02/05/2013

Labeler - TWIN MED, LLC (009579330)

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