Label: FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- neomycin sulfate, polymyxin b sulfate, and pramoxine hci cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 55319-033-28 - Packager: FAMILY DOLLAR
- 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 January 31, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
Active ingredients (in each gram) Purpose
Neomycin 3.5mg .......................................................................................................First aid antibiotic
Polymyxin B sulfate 10,000 units ................................................................................First aid antibiotic
Pramoxine hydrochloride 10mg ...................................................................................Pain reliever
- 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
-
INGREDIENTS AND APPEARANCE
FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
neomycin sulfate, polymyxin b sulfate, and pramoxine hci creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-033 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) WATER (UNII: 059QF0KO0R) PROPYLPARABEN (UNII: Z8IX2SC1OH) CETYL ALCOHOL (UNII: 936JST6JCN) PARAFFIN (UNII: I9O0E3H2ZE) STEARIC ACID (UNII: 4ELV7Z65AP) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) POLYSORBATE 60 (UNII: CAL22UVI4M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-033-28 1 in 1 CARTON 10/15/2012 1 28 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 10/15/2012 Labeler - FAMILY DOLLAR (024472631)