Label: DCH CALASPRAY ITCH RELIEF- pramoxine hcl 1%, zinc acetate 0.1% spray

  • NDC Code(s): 72839-013-03
  • Packager: Derma Care Research Labs, LLC
  • 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 June 8, 2023

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  • ACTIVE INGREDIENT

    Pramoxine HCl 2%, Zinc Acetate 0.1%

  • PURPOSE


    Topical Analgesic, Skin Protectant

  • INDICATIONS & USAGE

    For the temporary relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, and rashes due to poison ivy, oak, and sumac. Dries the oozing and weeping of poison ivy, oak, and sumac.

  • WARNINGS

    For external use only. Flammable--Keep away from fire or flame. Do not use on deep or puncture wounds, animal bites, or serious burns. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Shake well before use. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor. To apply to face, spray into palm of hand and gently apply.

  • INACTIVE INGREDIENT

    Alcohol Denat., Camphor, Citric Acid, Ethylhexylglycerin, Fragrance, glycerin, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polysorbate 40, Propylene Glycol, Sodium Citrate, Water.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    DCH CALASPRAY ITCH RELIEF 
    pramoxine hcl 1%, zinc acetate 0.1% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 40 (UNII: STI11B5A2X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-013-0385 g in 1 CAN; Type 0: Not a Combination Product02/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/18/2021
    Labeler - Derma Care Research Labs, LLC (116817470)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(72839-013)
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