Label: CALAMINE PLUS PRAMOXINE HCL- calamine plus no-touch aerosol, spray

  • 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 30, 2023

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  • Active ingredient

    Calamine 8%
    Pramoxine HCl 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. Use only as directed. Intentional misuse by deliberately concentrating and inhailing contents can be harmful or fatal.

    ​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.

    ​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

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

    ​Keep out of 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

    Walgreens

    Calamine Plus

    Itch Relief

    Spray

    CALAMINE 8% / SKIN PROTECTANT

    PRAMOXINE HYDROCHLORIDE 1% /

    EXTERNAL ANALGESIC

    NO TOUCH SPRAY

    • Relieves itching and pain associated with insect bites, poison ivy, oak & sumac
    • Relieves minor skin irritations & cuts
    • Sprays & dries pink


    NET WT 4.1 OZ (116g)

    calamine plus spray

  • INGREDIENTS AND APPEARANCE
    CALAMINE PLUS PRAMOXINE HCL 
    calamine plus no-touch aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-8588
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.345 mg  in 177 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24.16 mg  in 177 mL
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE2.72 mg  in 177 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    ISOBUTANE (UNII: BXR49TP611)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-8588-41177 mL in 1 CANISTER; Type 0: Not a Combination Product03/12/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/12/2013
    Labeler - Walgreens Company (008965063)
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