RENEW PERIPROTECT- skin protectant ointment 
DermaRite Industries, LLC

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.

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Renew Periprotect

​Active Ingredients:

Zinc Oxide 12%

Dimethicone 1%

Purpose:

Skin Protectant

Uses:

diaper rash and helps seal out wetness.

​Warnings:

Warnings:

Stop use and ask a doctor If

• condition worsens
• symptoms last more than 7 days or clear up and
occur again within a few days.

Warnings:

Keep out of reach of children.

In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions:

Other Information:

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.

Questions?

Call 800-337-6296 Mon - Fri 9AM - 5PM EST.

Renew Periprotect Package Label Principal Display Panel

Case LabelPackage Label and Principal Display Panel

RENEW PERIPROTECT 
skin protectant ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-435
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61924-435-04114 g in 1 TUBE; Type 0: Not a Combination Product10/18/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/18/2016
Labeler - DermaRite Industries, LLC (883925562)
Registrant - DermaRite Industries, LLC (883925562)
Establishment
NameAddressID/FEIBusiness Operations
DermaRite Industries, LLC883925562manufacture(61924-435)

Revised: 1/2022
Document Id: d58c7e3a-05d3-c446-e053-2a95a90a5495
Set id: 5bd49bb0-03a7-562c-e053-2a91aa0a19d8
Version: 3
Effective Time: 20220114
 
DermaRite Industries, LLC