Label: GENRX DAILY DEFENSE SKIN REPAIRING- dimethicone cream
- NDC Code(s): 59088-829-01, 59088-829-05, 59088-829-08, 59088-829-69
- 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 April 14, 2020
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- Official Label (Printer Friendly)
- Active ingredient
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera) leaf juice, butylene glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, GenRx 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.
- Daily Defense Skin Repairing Cream with GenRx Complex TM (4 fl. oz tube label)
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INGREDIENTS AND APPEARANCE
GENRX DAILY DEFENSE SKIN REPAIRING
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59088-829 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 17.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength KUKUI NUT OIL (UNII: TP11QR7B8R) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SAFFLOWER OIL (UNII: 65UEH262IS) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK) 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:59088-829-69 144 in 1 CARTON 01/08/2013 03/14/2019 1 NDC:59088-829-01 4 mL in 1 POUCH; Type 0: Not a Combination Product 2 NDC:59088-829-05 59 mL in 1 TUBE; Type 0: Not a Combination Product 01/08/2013 03/14/2019 3 NDC:59088-829-08 118 mL in 1 TUBE; Type 0: Not a Combination Product 01/08/2013 03/14/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/08/2013 Labeler - PureTek Corporation (785961046)
