Label: FAMILY CARE TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin neomycin sulfate polymyxin b sulfate pramoxine hydrochloride ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 65923-523-14 - Packager: United Exchange Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 15, 2016
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ACTIVE INGREDIENT
Active ingredients (in each gram) Purpose
Bacitracin 500 units....................................................................... First aid antibiotic
Neomycin sulfate 3.5 mg................................................................ First aid antibiotic
Polymyxin B sulfate 10,000 units...................................................... First aid antibiotic
Pramoxine hydrochloride 10mg........................................................ First aid antibiotic
- PURPOSE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FAMILY CARE TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
bacitracin neomycin sulfate polymyxin b sulfate pramoxine hydrochloride ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-523 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 10000 [USP'U] in 1 g BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) PARAFFIN (UNII: I9O0E3H2ZE) METHYLPARABEN (UNII: A2I8C7HI9T) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) PROPYLPARABEN (UNII: Z8IX2SC1OH) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-523-14 1 in 1 CARTON 09/15/2016 1 14 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 11/24/2014 Labeler - United Exchange Corp. (840130579) Registrant - United Exchange Corp. (840130579)