Label: POMADA DE LA CAMPANA TRIPLE ANTIBIOTIC PAIN RELIEF- bacitracin, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50066-013-14 - Packager: Genomma Lab USA, Inc.
- 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 October 27, 2016
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ACTIVE INGREDIENT
Active Ingredients Purpose
Bacitracin 500 units per gm-------------------------------------------------------------------------First Aid Antibiotic
Neomycin 3.5 mg per gm---------------------------------------------------------------------------First Aid Antibiotic
Polymyxin B 10,000 units per gm------------------------------------------------------------------First Aid Antibiotic
Pramoxine Hydrochoride 10mg---------------------------------------------------------------------First Aid Antibiotic
- PURPOSE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- 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
POMADA DE LA CAMPANA TRIPLE ANTIBIOTIC PAIN RELIEF
bacitracin, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 10000 [USP'U] in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength 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:50066-013-14 1 in 1 CARTON 10/27/2016 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 06/30/2014 Labeler - Genomma Lab USA, Inc. (832323534)