Label: CALAMINE PLUS PRAMOXINE HCL- calamine plus spray 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 December 22, 2017

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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.

    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 as needed to the affected area, not more than 3 or 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

    HyVee Health 

    Calamine Plan Spray

    Calamine 8% - Skin Protectant

    Promoxine HCL 1% - External Analgesic

    Drying action plus itch relief

    Ideal for: poison ivy/ oak/ sumac

    insect bites, minor skin irritations & cuts

    SHAKE WELL BEFORE USE

    NET WT 4.1 OZ (116 g)

    Hyvee_Calamine Spray_50-074HY-01.jpg

  • INGREDIENTS AND APPEARANCE
    CALAMINE PLUS PRAMOXINE HCL 
    calamine plus spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-147
    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 116 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION24.16 mg  in 116 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE2.72 mg  in 116 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    ISOBUTANE (UNII: BXR49TP611)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42507-147-41116 g in 1 CANISTER; Type 0: Not a Combination Product12/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/22/2017
    Labeler - HY-VEE, INC (006925671)
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