Label: RENEW PERIPROTECT- skin protectant ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 61924-435-04 - 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 14, 2022
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- Active Ingredients:
- Purpose:
- Uses:
- Warnings:
- Warnings:
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Inactive Ingredients:
Aloe Barbadensis Leaf Juice, Aluminum Stearate, Beeswax, Cholecalciferol, Chloroxylenol, Corn Oil, Imidazolidinyl Urea, 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 PERIPROTECT
skin protectant ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61924-435 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12 g in 100 g DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) 2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL (UNII: 1ZRR9A405A) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) TOCOPHERYL RETINOATE (UNII: 0WN694NBMM) WATER (UNII: 059QF0KO0R) N-(1,3,4-TRIS(HYDROXYMETHYL)-2,5-DIOXO-4-IMIDAZOLIDINYL)-N,N'-BIS(HYDROXYMETHYL)UREA (UNII: ENL2IA4WGW) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) CHOLECALCIFEROL (UNII: 1C6V77QF41) ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517) ALUMINUM STEARATE (UNII: U6XF9NP8HM) YELLOW WAX (UNII: 2ZA36H0S2V) CORN OIL (UNII: 8470G57WFM) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) METHYLPARABEN (UNII: A2I8C7HI9T) CHLOROXYLENOL (UNII: 0F32U78V2Q) LANOLIN (UNII: 7EV65EAW6H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61924-435-04 114 g in 1 TUBE; Type 0: Not a Combination Product 10/18/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 10/18/2016 Labeler - DermaRite Industries, LLC (883925562) Registrant - DermaRite Industries, LLC (883925562) Establishment Name Address ID/FEI Business Operations DermaRite Industries, LLC 883925562 manufacture(61924-435)