Label: ANTIBIOTIC- neomycin, polymyxin b, pramoxine hcl cream
- NDC Code(s): 37808-005-58
- Packager: H E B
- 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 December 5, 2019
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- Active ingredients (in each gram)
- Purpose
- Uses
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Warnings
For external use only.
Do not use
- •
- if you are allergic to any of the ingredients
- •
- in the eyes
- •
- over large areas of the body
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
ANTIBIOTIC
neomycin, polymyxin b, pramoxine hcl creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-005 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 PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 10000 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) POLOXAMER 188 (UNII: LQA7B6G8JG) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-005-58 1 in 1 CARTON 09/14/2015 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 09/14/2015 Labeler - H E B (007924756)