Label: PERIGUARD- otc skin protectant drug products 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 13, 2022

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  • Active Ingredient:

    Petrolatum 49.9%

  • Purpose:

    Skin Protectant

  • Uses:

    A moisture barrier that prevents and helps treat skin irritation from urine, feces, perspiration, conditions associated with diaper rash from incontinence.

  • Warnings:

    • For external use only.
    • Avoid contact with eyes.In case of contact, flush thoroughly with water.
    • Stop use and ask doctor if condition worsens or does not improve within 7 days.
    • In case of accidental ingestion contact a physician or Poison Control Center right away.
  • Warnings:

    • Keep out of reach of children. If swallowed, contact a physician or Poison Control Center right away.
  • Directions:

    Cleanse skin gently with a mild cleanser. Pat dry or allow to dry. Apply a thin layer of ointment to the affected area as necessary, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

  • Other Information:

    Store at room temperature (59 o- 86 oF)

  • Inactive Ingredients:

    Water, Lanolin, Mineral Oil, Paraffin, Zinc Oxide, Sorbitan Sequioleate, Beeswax, Propylene Glycol, Imidazolidinyl Urea, Methylparaben,propylparaben, Aluminum Stearate, Phenoxyethanol, Fragrance, Chloroxylenol,Cholecalciferol, Retinyl Palmitate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Zea Mays (corn) Oil

  • Questions?

    Call 1-800-37-6296

  • Periguard Package Label Principal Display Panel

    PeriGuard

  • INGREDIENTS AND APPEARANCE
    PERIGUARD 
    otc skin protectant drug products ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM49.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM STEARATES (UNII: O4D7U3B46U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CORN OIL (UNII: 8470G57WFM)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    IMIDUREA (UNII: M629807ATL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61924-205-04100 g in 1 TUBE; Type 0: Not a Combination Product04/18/2011
    2NDC:61924-205-07198 g in 1 TUBE; Type 0: Not a Combination Product04/18/2011
    3NDC:61924-205-055 g in 1 PACKET; Type 0: Not a Combination Product04/18/2011
    4NDC:61924-205-1515 g in 1 PACKET; Type 0: Not a Combination Product04/18/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/18/2011
    Labeler - DermaRite Industries, LLC (883925562)
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