Label: FIRST AID ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hcl ointment
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- NDC Code(s): 0363-0841-58, 0363-0841-64
- Packager: Walgreen Company
- 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 July 6, 2017
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- Official Label (Printer Friendly)
- Active ingredients (in each gram)
Bacitracin zinc 500 units
Neomycin sulfate equivalent to 3.5 mg of neomycin base
Polymyxin B 10,000 units as polymyxin B sulfate
Pramoxine HCl 10 mg
Close - Purpose
- Uses
first aid to help prevent infection and for temporary relief of pain or discomfort in minor:
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- cuts
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- scrapes
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- burns
- Warnings
- Do not use
- Ask a doctor before use if you have
- Stop use and ask a doctor if
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- you need to use longer than 1 week
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- condition persists or gets worse
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- symptoms persist for more than 1 week, or clear up and occur again within a few days
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- rash or other allergic reaction develops
- Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Close - Directions
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- adults and children 2 years of age and older:
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- clean the affected area
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- apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
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- may be covered with a sterile bandage
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- children under 2 years of age: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
Minimizes the appearance of scars
Maximum strength pain & itch relief
Long-lasting infection protection
Compare to Neosporin® + Pain Itch Scar active ingredients
PAIN – ITCH – SCAR
First Aid Antibiotic Ointment
BACITRACIN ZINC, NEOMYCIN SULFATE,
POLYMYXIN B SULFATE, PRAMOXINE HCl
FIRST AID ANTIBIOTIC / PAIN RELIEVING OINTMENT
NET WT 1 OZ (28 g)
Close - INGREDIENTS AND APPEARANCE
FIRST AID ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0841 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:0363-0841-58 1 in 1 CARTON 02/16/2017 1 14 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0363-0841-64 1 in 1 CARTON 02/16/2017 2 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 02/16/2017 CloseLabeler - Walgreen Company (008965063)
