Label: FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT VANILLA COOKIE- colloidal oatmeal cream
- NDC Code(s): 69423-708-56
- Packager: The Procter & Gamble Manufacturing Company
- 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 June 21, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
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INACTIVE INGREDIENT
Water, stearic acid, glycerin, c12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, glyceryl stearate se, cetearyl alcohol, dimethicone, squalane, butyrospermum parkii (shea) butter, phenoxyethanol, caprylyl glycol, xanthan gum, allantoin, sodium hydroxide, disodium edta, chrysanthemum parthenium (feverfew) extract, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, ceramide-3, lavandula angustifolia (lavender), myroxylon pereira (peru balsam) oil, vanillin
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 2.0 oz (56.7 g)
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INGREDIENTS AND APPEARANCE
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT VANILLA COOKIE
colloidal oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-708 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SQUALANE (UNII: GW89575KF9) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) SHEA BUTTER (UNII: K49155WL9Y) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALLANTOIN (UNII: 344S277G0Z) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STEARIC ACID (UNII: 4ELV7Z65AP) XANTHAN GUM (UNII: TTV12P4NEE) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) CERAMIDE NP (UNII: 4370DF050B) BALSAM PERU OIL (UNII: DIK0395679) VANILLIN (UNII: CHI530446X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-708-56 56.7 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 01/01/2021 Labeler - The Procter & Gamble Manufacturing Company (004238200)