Label: SKIN REPAIR COMPLEX- dimethicone cream
- NDC Code(s): 59088-333-08
- Packager: PureTek Corporation
- 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 11, 2023
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- Active ingredient
- Uses
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Inactive ingredients
Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, DermacinRx Complex ® [consisting of: bisabolol, calcium pantothenate (vitamin B 5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B 3), pyridoxine HCl (vitamin B 6), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine.
- DermacinRx ® Skin Repair Complex (4 oz tube label)
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INGREDIENTS AND APPEARANCE
SKIN REPAIR COMPLEX
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59088-333 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK) KUKUI NUT OIL (UNII: TP11QR7B8R) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SAFFLOWER OIL (UNII: 65UEH262IS) CETYL ALCOHOL (UNII: 936JST6JCN) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LEVOMENOL (UNII: 24WE03BX2T) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309) MALTODEXTRIN (UNII: 7CVR7L4A2D) NIACINAMIDE (UNII: 25X51I8RD4) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) GINGER (UNII: C5529G5JPQ) PEG-100 STEARATE (UNII: YD01N1999R) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) HYALURONATE SODIUM (UNII: YSE9PPT4TH) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59088-333-08 118 mL in 1 TUBE; Type 0: Not a Combination Product 05/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/01/2015 Labeler - PureTek Corporation (785961046)