Label: DERMASARRA- otc topical analgesic drug products lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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

    Camphor 0.5%

  • Purpose

    External Analgesic

  • Uses:

    Temporary relief of itching associiated with minor skin irritations due to:

    • dry skin
    • insect bites
    • detergent
    • sunburn
  • Warnings:

    • For external use only.
    • Avoid contact with eyes. In case of contact, flush thoroughly with water.
    • Stop use and ask a doctor if, condition worsens, symptoms last for more than 7 days, symptoms clear up and occur again within a few days
    • Do not use on deep puncture wounds, animal bites, or serious burns.
  • Warnings

    • Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away
  • Directions:

    Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times dialy,

    Children under 2 years of age: Consult a doctor

  • Other Infomation:

    Store at room temperature (59°-86°F)

    You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

  • Inactive Ingredients:

    water, Cetearyl Alcohol, PEG-40 Castor Oil, Sodium Cetearyl Sulfate, Stearic Acid, Glycol Stearate, Mineral Oil, Dimethicone, PEG-4 Dilaurate, Propylene Glycol, Imidazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine, Titanium Dioxide, menthol, Carbomer, Petrolatum, Disodium EDTA

  • BOXED WARNING (What is this?)

    Questions?

    Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

  • DermaSarra Package Label Principal Display Panel

    Package.Label Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    DERMASARRA 
    otc topical analgesic drug products lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-189
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.005 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    IMIDUREA (UNII: M629807ATL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    PEG-4 DILAURATE (UNII: KCR71CW036)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    MENTHOL (UNII: L7T10EIP3A)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61924-189-08222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/24/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/24/2010
    Labeler - DERMARITE INDUSTRIES, LLC (883925562)
    Registrant - DERMARITE INDUSTRIES, LLC (883925562)
    Establishment
    NameAddressID/FEIBusiness Operations
    DERMARITE INDUSTRIES, LLC883925562manufacture(61924-189)
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