Label: AVEENO RESTORATIVE SKIN THERAPY ITCH RELIEF BALM- pramoxine hydrochloride cream
- NDC Code(s): 69968-0637-4
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 9, 2023
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Inactive Ingredients
Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Panthenol, Dimethicone, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Cetyl Hydroxyethylcellulose, Chlorphenesin, Steareth-20, Aloe Barbadensis Leaf Extract, Sodium Chloride, Avena Sativa (Oat) Kernel Extract
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- PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
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INGREDIENTS AND APPEARANCE
AVEENO RESTORATIVE SKIN THERAPY ITCH RELIEF BALM
pramoxine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0637 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 5 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) PETROLATUM (UNII: 4T6H12BN9U) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) CETYL ALCOHOL (UNII: 936JST6JCN) PANTHENOL (UNII: WV9CM0O67Z) DIMETHICONE (UNII: 92RU3N3Y1O) OATMEAL (UNII: 8PI54V663Y) BENZYL ALCOHOL (UNII: LKG8494WBH) CHLORPHENESIN (UNII: I670DAL4SZ) STEARETH-20 (UNII: L0Q8IK9E08) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM CHLORIDE (UNII: 451W47IQ8X) OAT (UNII: Z6J799EAJK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0637-4 1 in 1 CARTON 08/01/2020 1 113 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 not final part348 08/01/2020 Labeler - Johnson & Johnson Consumer Inc. (118772437)