Label: EQUATE CALASPRAY- pramoxine hcl 1%, zinc acetate 0.1% spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Pramoxine HCl 1%, Zinc acetate 0.1%

  • PURPOSE

    Topical analgesic / Skin protectant

  • INDICATIONS & USAGE

    For the temporary relief of pain and itching associated with

    • rashes due to poison ivy, oak and sumac
    • insect bites
    • minor skin irritations
    • minor cuts
    • 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.
    • avoid contact with broken skin,
    • do not inhale or ingest,
    • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

    Stop use and ask a doctor if condition worsens, rash or irritation develops and lasts for more than 7 days or clears up and occurs again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    If product is swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years or older: apply to affected are not more than 3 to 4 times daily. Children under 2 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
    EQUATE CALASPRAY 
    pramoxine hcl 1%, zinc acetate 0.1% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-212
    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
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYSORBATE 40 (UNII: STI11B5A2X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-212-0385 g in 1 CAN; Type 0: Not a Combination Product12/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/26/2023
    Labeler - Walmart Inc (051957769)
    Registrant - Derma Care Research Labs (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs116817470manufacture(79903-212)