Label: EQUATE FIRST AID ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
- NDC Code(s): 49035-840-01
- Packager: Wal-Mart
- 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 October 22, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
-
Warnings
For external use only.
Not for prolonged use.
Do not use
- in the eyes, nose, or over large areas of the body
- if you are allergic to any of the ingredients
- longer than 1 week unless directed by a doctor
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Directions
Adults and children 2 years of age and older:
- clean the affected area
- 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
- the affected area may be covered with a sterile bandage
Children under 2 years of age: consult a doctor
- Other information
- Inactive ingredient
- Questions or comments?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
NDC 49035-840-01
equate™
Compare
Neosporin®
+ Pain Relief
Active
Ingredients*Maximum Strength
First Aid
Antibiotic
+ Pain ReliefFirst Aid Antibiotic
Pain Relieving
OintmentBacitracin Zinc, Neomycin
Sulfate, Polymyxin B Sulfate,
Pramoxine HCl- Soothes painful cuts,
scrapes and burns while
preventing infection
NET WT 1 OZ (28g)
- Soothes painful cuts,
-
INGREDIENTS AND APPEARANCE
EQUATE FIRST AID ANTIBIOTIC PLUS PAIN RELIEF
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-840 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 SULFATE 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 PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-840-01 1 in 1 CARTON 10/18/2018 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 10/18/2018 Labeler - Wal-Mart (051957769) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(49035-840)