Label: TOPCARE ANTIBIOTIC- neomycin, polymyxin b, pramoxine hydrochloride cream
- NDC Code(s): 36800-976-58
- Packager: Topco Associates LLC
- 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 February 28, 2022
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- Official Label (Printer Friendly)
- 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
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- in the eyes
- •
- over large areas of the body
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Package/Label Principal Display Panel
COMPARE TO NEOSPORIN® + PAIN RELIEF ACTIVE INGREDIENTS
First Aid Antibiotic & Pain Relieving Cream
Helps Prevent Infection in Minor Cuts, Scrapes & Burns
Maximum Strength
TopCare® health
MAXIMUM STRENGTH
Antibiotic Cream + Pain Relief
NEOMYCIN SULFATE, POLYMYXIN B SULFATE & PRAMOXINE HCl
First Aid Antibiotic / Pain Relieving Cream
NET WT 0.5 OZ (14 g)
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INGREDIENTS AND APPEARANCE
TOPCARE ANTIBIOTIC
neomycin, polymyxin b, pramoxine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-976 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 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:36800-976-58 1 in 1 CARTON 04/03/2020 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 04/03/2020 Labeler - Topco Associates LLC (006935977)