Label: RENEW PERIPROTECT- skin protectant ointment

  • 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 January 14, 2022

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  • ​Active Ingredients:

    Zinc Oxide 12%

    Dimethicone 1%

  • Purpose:

    Skin Protectant

  • Uses:

    • Helps treat and prevent diaper rash.
    • Protects minor skin irritation associated with

    diaper rash and helps seal out wetness.

  • ​Warnings:

    • For external use only,
    • Avoid contact with eyes, In case of contact, flush thoroughly with water.
  • 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:

    • Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry.
    • Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • Other Information:

    • Store at room temperature (59º-86ºF)
    • You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047.
  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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