Label: CALAMINE PLUS- calamine plus pramoxine hcl aerosol, spray

  • NDC Code(s): 83324-242-41
  • Packager: Chain Drug Marketing Association Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

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  • Active ingredients

    Calamine 8%

    Pramoxine HCI 1%

  • Purpose

    Skin protectant

    External analgesic

  • Uses

    temporarily relieves pain and itching associated with:

    • insect bites
    • rashes
    • minor skin irritations
    • minor cuts
    • dries the oozing and weeping of poison ivy, poison oak and poison sumac
  • Warnings

    For external use only.

    Flammable:

    Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

    When using this product

    • do not get into eyes
    • ask a doctor before using on children under 2 years of age

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again in a few days

    Keep out of the reach of children.

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

  • Directions

    • shake well before using
    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • cleanse the skin with soap and water
    • let dry before use
    • children under 2 years of age: consult a doctor

    Other Information

    store between 20° to 25°C (68° to 77°F)

  • Inactive ingredients

    benzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate

  • Questions?

    Call 1-866-964-0939

  • Principal Display Panel

    QC

    QUALITY CHOICE

    No-Rub

    NO-RUB

    Calamine

    Plus Spray

    Calamine 8% / Skin Protectant

    Pramoxine HCI 1% / External analgesic

    Relieves itching from poison ivy,

    oak & sumac, & insect bites

    Soothes minor skin irritations & cuts

    Shake well before use

    NET WT 4.1 OZ. (116 g)

    label

  • INGREDIENTS AND APPEARANCE
    CALAMINE PLUS 
    calamine plus pramoxine hcl aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-242
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED5 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE79.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    ISOBUTANE (UNII: BXR49TP611)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83324-242-41116 g in 1 CANISTER; Type 0: Not a Combination Product06/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/07/2024
    Labeler - Chain Drug Marketing Association Inc (011920774)
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