Label: MEDLINE REMEDY PHYTOPLEX SKIN REPAIR- dimeticone cream
- NDC Code(s): 53329-995-04, 53329-995-13, 53329-995-23, 53329-995-84
- Packager: Medline Industries, LP
- 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 December 15, 2022
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- Active ingredient
- Purpose
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- Warnings
- Directions
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Inactive ingredients
aphanizomenon flos-aquae (algae) extract, bisabolol, brassica campestris (rapeseed) sterols, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, caprylyl glycol, carthamus tinctorius (safflower) oleosomes, cetyl alcohol, cetylhydroxyproline palmitamide, cholecalciferol, cocos nucifera (coconut oil), 7-dehydrocholesterol, eugenia caryophyllus (clove) flower extract, glycerin, glyceryl stearate, glycol distearate, 1,2-hexanediol, hexyldecanol, hydrolyzed soy protein, hydroyacetophenone, jojoba esters, manuka honey, olea europaea (olive oil), peg 100 stearate, phospholipids, phytonadione, propanediol, stearic acid, tocopherol acetate, water, yeast ferment extract, zea mays (corn) oil
- Manufacturing Information
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INGREDIENTS AND APPEARANCE
MEDLINE REMEDY PHYTOPLEX SKIN REPAIR
dimeticone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-995 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength HEXANEDIOL (UNII: ZIA319275I) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) GLYCOL DISTEARATE (UNII: 13W7MDN21W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) STEARIC ACID (UNII: 4ELV7Z65AP) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CORN OIL (UNII: 8470G57WFM) PROPANEDIOL (UNII: 5965N8W85T) WATER (UNII: 059QF0KO0R) APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X) LEVOMENOL (UNII: 24WE03BX2T) HEXYLDECANOL (UNII: 151Z7P1317) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) RAPESEED STEROL (UNII: B46B6DD20U) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) OLIVE OIL (UNII: 6UYK2W1W1E) PEG-100 STEARATE (UNII: YD01N1999R) PHYTONADIONE (UNII: A034SE7857) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G) CLOVE (UNII: K48IKT5321) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL ALCOHOL (UNII: 936JST6JCN) COCONUT OIL (UNII: Q9L0O73W7L) 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF) GLYCERIN (UNII: PDC6A3C0OX) JOJOBA OIL (UNII: 724GKU717M) HONEY (UNII: Y9H1V576FH) CHOLECALCIFEROL (UNII: 1C6V77QF41) GREEN TEA LEAF (UNII: W2ZU1RY8B0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-995-04 118 mL in 1 TUBE; Type 0: Not a Combination Product 11/01/2019 2 NDC:53329-995-13 59 mL in 1 TUBE; Type 0: Not a Combination Product 11/01/2019 3 NDC:53329-995-23 946 mL in 1 TUBE; Type 0: Not a Combination Product 11/01/2019 4 NDC:53329-995-84 1000 mL in 1 BAG; Type 0: Not a Combination Product 11/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 11/01/2019 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)
