Label: EXTRA STRENGTH BODY- colloidal oatmeal cream
- NDC Code(s): 61328-119-28
- Packager: Skinfix, 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 30, 2022
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- Active Ingredients
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Directions
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Inactive Ingredients
Water/Eau/Aqua, Glycerin, Caprylic/Capric Triglyceride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Stearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-2 Stearate, Caprylyl Caprylate/Caprate, Glyceryl Stearate, Vitis Vinifera (Grape) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Phenoxyethanol, Oryza Sativa (Rice) Bran Extract, Avena Sativa (Oat) Kernel Oil, Allantoin, Xanthan Gum, Avena Sativa (Oat) Bran Extract, Potassium Sorbate, Citric Acid, Rosmarinus Officinalis (Rosemary) Leaf Extract, Ethylhexylglycerin, Moringa Oil/Hydrogenated Moringa Oil Esters, Simmondsia Chinensis (Jojoba) Seed Oil, Trisodium Ethylenediamine Disuccinate, Aloe Barbadensis Leaf Juice, Tocopherol, Helianthus Annuus (Sunflower) Extract.
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH BODY
colloidal oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61328-119 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 2 g in 100 mL Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG) OAT KERNEL OIL (UNII: 3UVP41R77R) SHEA BUTTER (UNII: K49155WL9Y) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SUNFLOWER OIL (UNII: 3W1JG795YI) HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR) MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0) RICE BRAN (UNII: R60QEP13IC) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ALMOND OIL (UNII: 66YXD4DKO9) ROSEMARY (UNII: IJ67X351P9) JOJOBA OIL (UNII: 724GKU717M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TOCOPHEROL (UNII: R0ZB2556P8) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) GRAPE SEED OIL (UNII: 930MLC8XGG) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61328-119-28 236 mL in 1 TUBE; Type 0: Not a Combination Product 01/30/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/30/2022 Labeler - Skinfix, Inc. (203158183) Registrant - Skinfix, Inc. (203158183) Establishment Name Address ID/FEI Business Operations Canadian Custom Packaging Company 207062514 manufacture(61328-119)