Label: NATUREPLEX ANTIBIOTIC PLUS PAIN RELIEF- neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
- NDC Code(s): 67234-068-01, 67234-068-02
- Packager: Natureplex
- 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 December 16, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
Warnings
For external use only.
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?
- PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
-
INGREDIENTS AND APPEARANCE
NATUREPLEX ANTIBIOTIC PLUS PAIN RELIEF
neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-068 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 9.4 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 10000 [iU] in 9.4 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 9.4 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:67234-068-01 1 in 1 CARTON 12/06/2018 1 9.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:67234-068-02 1 in 1 CARTON 12/14/2021 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 12/06/2018 Labeler - Natureplex (062808196) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(67234-068)