NDC | 49035-847-05 |
Set ID | e08b427f-d070-4521-ad3c-faf295531791 |
Category | HUMAN OTC DRUG LABEL |
Packager | WalMart |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 14 g Tube Carton
-
INGREDIENTS AND APPEARANCE
EQUATE ANTIBIOTIC PLUS PAIN RELIEF
neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-847 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 cetostearyl alcohol (UNII: 2DMT128M1S) methylparaben (UNII: A2I8C7HI9T) mineral oil (UNII: T5L8T28FGP) petrolatum (UNII: 4T6H12BN9U) polysorbate 60 (UNII: CAL22UVI4M) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-847-05 1 in 1 CARTON 10/18/2018 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 10/18/2018 Labeler - WalMart (051957769) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(49035-847)