CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO TOUCH SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]

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CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO TOUCH SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]
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NDC 56104-031-41
Set ID 8ec89d0e-c921-47d3-9b20-cdf403dc66cf
Category HUMAN OTC DRUG LABEL
Packager Premier Brands of America Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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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
    • cleanse the skin with soap and water
    • let dry before use
    • apply as needed to the affected area, not more than 3 or 4 times daily
  • ​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

    Premier
    Calamine Plus
    No-Touch Spray

    • External analgesic & skin protectant
    • Drying action plus itch relief
    • Ideal for poison ivy/oak/sumac, insect bites, minor skin irritations & cuts

    Shake well before using

    6.0 FL OZ (177mL)
    Net Wt 4.1 OZ (116g)

    PB Calamine Spray.jpg

  • INGREDIENTS AND APPEARANCE
    CALAMINE PLUS PRAMOXINE HCL 
    calamine plus no touch spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-031
    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:56104-031-41177 mL in 1 CANISTER; Type 0: Not a Combination Product01/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2013
    Labeler - Premier Brands of America Inc. (117557458)
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