Label: FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT PINK GRAPEFRUIT- colloidal oatmeal cream
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NDC Code(s):
69423-567-17,
69423-567-23,
69423-567-34,
69423-567-39, view more69423-567-56, 69423-567-57
- 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 January 6, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
- Warnings
- Directions
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INACTIVE INGREDIENT
Water, stearic acid, glycerin, c12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, glyceryl stearate SE, cetearyl alcohol, butyrospermum parkii (shea) butter, dimethicone, squalene, phenoxyethanol, caprylyl glycol. xanthan gum, citrus paradisi, citrus reticulata (tangerine) peel oil. Orange terpenes, allantoin, sodium hydroxide, tetrasodium EDTA, chrysanthemum parthenium (feverfew) extract, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, ceramide NP
- Questions:
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 14.0 oz (396.8 g)
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INGREDIENTS AND APPEARANCE
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT PINK GRAPEFRUIT
colloidal oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-567 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 GRAPEFRUIT (UNII: O82C39RR8C) 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) MANDARIN OIL (UNII: NJO720F72R) CERAMIDE NP (UNII: 4370DF050B) ORANGE TERPENES (UNII: 9J3RG7FX7S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-567-57 56.7 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2021 09/10/2022 2 NDC:69423-567-56 56.7 g in 1 JAR; Type 0: Not a Combination Product 01/01/2021 09/10/2022 3 NDC:69423-567-17 170.1 g in 1 JAR; Type 0: Not a Combination Product 01/01/2021 09/10/2022 4 NDC:69423-567-23 226 g in 1 JAR; Type 0: Not a Combination Product 01/01/2021 09/10/2022 5 NDC:69423-567-34 340.2 g in 1 JAR; Type 0: Not a Combination Product 01/01/2021 6 NDC:69423-567-39 396.8 g in 1 JAR; 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)