Label: SKINFIX HAND REPAIR- oatmeal cream
- NDC Code(s): 61328-106-11, 61328-106-13
- 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 December 24, 2022
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- Active Ingredients
- Purpose
- Warnings
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- Uses
- Directions
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Inactive Ingredients:
allantoin, aloe barbadensis leaf juice, avena sativa kernel oil, beeswax, butyrospermum parkii (shea) butter, calendula officinalis extract, capyrlic/capric triglyceride, caprylyl-caprylate/caprate, chamomilla recutita (matricaria) flower extract, citric acid, ethylhexylglycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, oryza sativa (rice) bran extract, petrolatum, phenoxyethanol, polyglyceryl-2-stearate, potassium sorbate, prunus amygdalus dulcis (sweet almond) oil, rosmarinus officinalis (rosemary) leaf extract, simmondsia chinensis (jojoba) seed oil, stearyl alcohol, tocopherol, trisodium ethylenediamine disuccinate, water (aqua), xanthan gum
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INGREDIENTS AND APPEARANCE
SKINFIX HAND REPAIR
oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61328-106 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 1 g in 100 mL Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) OAT KERNEL OIL (UNII: 3UVP41R77R) YELLOW WAX (UNII: 2ZA36H0S2V) SHEA BUTTER (UNII: K49155WL9Y) CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR) MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SUNFLOWER OIL (UNII: 3W1JG795YI) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) PETROLATUM (UNII: 4T6H12BN9U) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M) JOJOBA OIL (UNII: 724GKU717M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TOCOPHEROL (UNII: R0ZB2556P8) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61328-106-13 90 mL in 1 TUBE; Type 0: Not a Combination Product 07/02/2014 2 NDC:61328-106-11 30 mL in 1 TUBE; Type 0: Not a Combination Product 09/23/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/02/2014 Labeler - Skinfix, Inc. (203158183) Registrant - Skinfix, Inc. (203158183) Establishment Name Address ID/FEI Business Operations SIGAN INDUSTRIES INC 255106239 manufacture(61328-106)