Label: AVEENO SKIN RELIEF OVERNIGHT- dimethicone cream
- NDC Code(s): 69968-0488-7
- Packager: Johnson & Johnson Consumer Inc.
- 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 January 6, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredient
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Inactive ingredients
water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, avena sativa (oat) kernel flour, benzyl alcohol, avena sativa (oat) kernel oil, steareth-20, methylparaben, sodium chloride, butyrospermum parkii (shea) butter, propylene glycol, chamomilla recutita (matricaria) flower extract, avena sativa (oat) kernel extract
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 207 g Tube Label
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INGREDIENTS AND APPEARANCE
AVEENO SKIN RELIEF OVERNIGHT
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0488 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 12 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) OATMEAL (UNII: 8PI54V663Y) BENZYL ALCOHOL (UNII: LKG8494WBH) OAT KERNEL OIL (UNII: 3UVP41R77R) STEARETH-20 (UNII: L0Q8IK9E08) METHYLPARABEN (UNII: A2I8C7HI9T) OAT (UNII: Z6J799EAJK) SODIUM CHLORIDE (UNII: 451W47IQ8X) SHEA BUTTER (UNII: K49155WL9Y) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0488-7 207 g in 1 TUBE; Type 0: Not a Combination Product 05/22/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/22/2007 Labeler - Johnson & Johnson Consumer Inc. (118772437)