Label: AVEENO CALM PLUS RESTORE ITCH RELIEF BALM- pramoxine hydrochloride cream
- NDC Code(s): 69968-0796-4
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
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 5, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other Information
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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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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 113g Tube Carton
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INGREDIENTS AND APPEARANCE
AVEENO CALM PLUS RESTORE ITCH RELIEF BALM
pramoxine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0796 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) CETYL ALCOHOL (UNII: 936JST6JCN) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM CHLORIDE (UNII: 451W47IQ8X) PANTHENOL (UNII: WV9CM0O67Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) STEARETH-20 (UNII: L0Q8IK9E08) CHLORPHENESIN (UNII: I670DAL4SZ) DIMETHICONE (UNII: 92RU3N3Y1O) OATMEAL (UNII: 8PI54V663Y) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) OAT (UNII: Z6J799EAJK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0796-4 1 in 1 CARTON 07/03/2023 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 07/03/2023 Labeler - Johnson & Johnson Consumer Inc. (118772437)