Label: RENEW DIMETHICONE SKIN PROTECTANT- skin protectant cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61924-410-04, 61924-410-05 - Packager: Dermarite Industries LLC
- 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 17, 2020
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- Active Ingredient:
- Purpose:
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Inactive Ingredients:
Aloe Barbadensis Leaf Juice, Aluminum Stearate, Cera Alba, Cholecalciferol, Chloroxylenol, Corn Oil, Imidiazolidinyl Urea, Dicocoyl Pentaerythrityl Distearyl Citrate, Fragrance, Lanolin, Methylparaben, Mineral Oil, Paraffin wax, Petrolatum, Phenoxyethanol, Propylene Glycol, Propylparaben, Retinyl Palmitate, Sorbitan Sesquioleate, Tocopheryl Acetate, Water.
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INGREDIENTS AND APPEARANCE
RENEW DIMETHICONE SKIN PROTECTANT
skin protectant creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61924-410 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.05 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ASCORBYL PALMITATE (UNII: QN83US2B0N) BUTYLPARABEN (UNII: 3QPI1U3FV8) CANOLA OIL (UNII: 331KBJ17RK) CARBOMER 940 (UNII: 4Q93RCW27E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHOLECALCIFEROL (UNII: 1C6V77QF41) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) METHYLPARABEN (UNII: A2I8C7HI9T) NIACINAMIDE (UNII: 25X51I8RD4) OLIVE OIL (UNII: 6UYK2W1W1E) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) CORN OIL (UNII: 8470G57WFM) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61924-410-05 5 g in 1 PACKET; Type 0: Not a Combination Product 03/15/2012 2 NDC:61924-410-04 113 g in 1 TUBE; Type 0: Not a Combination Product 03/15/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/15/2012 Labeler - Dermarite Industries LLC (883925562) Registrant - Dermarite Industries LLC (883925562) Establishment Name Address ID/FEI Business Operations Dermarite Industries LLC 883925562 manufacture(61924-410)