Label: DERMACERIN- 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 Ingredient:

    Petrolatum 33%

  • Purpose:

    Skin Protectant

  • Uses:

    • Temporarily protects and helps relieve dry, chapped, or cracked skin.
    • Helps protect skin from the drying effects of wind and cold weather.
  • Warnings:

    For external use only.​

    Avoid contact with eyes. In case of contact, flush thoroughly with water

  • Warnings:

    Stop and ask a doctor if

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

    Do not use ​on deep or puncture wounds, animal bites, or serious wounds.

  • Warnings:

    Keep out of reach of children.

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

  • ​Directions:

    Apply as needed or as directed by a physician.

  • 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:

    Water, Mineral Oil, Paraffin, Lanolin Alcohol, PEG-30 Dipolhydroxystearate, DMDM Hydantoin, Methylparaben, Propylparaben, Propylene Glycol, Sodium Chloride

  • ​Questions?

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

  • DermaCerin Package Label and Principal Display Panel

    Package LabelCarton LabelPackage Label

  • INGREDIENTS AND APPEARANCE
    DERMACERIN 
    skin protectant ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-174
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM33 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLENE GLYCOL 2-(2-METHYLBUTYRATE) (UNII: 3Z73C506A9)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61924-174-04106 g in 1 TUBE; Type 0: Not a Combination Product10/17/2016
    2NDC:61924-174-08198 g in 1 TUBE; Type 0: Not a Combination Product10/17/2016
    3NDC:61924-174-16454 g in 1 JAR; Type 0: Not a Combination Product10/17/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/17/2016
    Labeler - DermaRite Industries, LLC (883925562)
    Registrant - DermaRite Industries, LLC (883925562)
    Establishment
    NameAddressID/FEIBusiness Operations
    DermaRite Industries, LLC883925562manufacture(61924-174)
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