Label: SIGNATURE CARE TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hcl ointment
- NDC Code(s): 21130-120-58
- Packager: Safeway
- 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 March 10, 2021
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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
- •
- 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 Itch Scar active ingredients
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Triple Antibiotic Ointment + Pain – Itch – Scar
First aid antibiotic
Pain relieving ointment
BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCI
MULTI-ACTION OINTMENT
Maximum strength pain and itch relief
NET WT 0.5 OZ (14 g)
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INGREDIENTS AND APPEARANCE
SIGNATURE CARE TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (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 COCOA BUTTER (UNII: 512OYT1CRR) OLIVE OIL (UNII: 6UYK2W1W1E) PETROLATUM (UNII: 4T6H12BN9U) SODIUM PYRUVATE (UNII: POD38AIF08) COTTONSEED OIL (UNII: H3E878020N) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Product Characteristics Color YELLOW (Pale) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-120-58 1 in 1 CARTON 05/09/2017 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 05/09/2017 Labeler - Safeway (009137209)