CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [FOODHOLD USA]

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CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [FOODHOLD USA]
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NDC 41520-184-41
Set ID 7cad7ad7-347a-6992-e053-2a91aa0a9ad6
Category HUMAN OTC DRUG LABEL
Packager Foodhold USA
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.

    Flammable:

    Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by delibrately 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

    • conditions worsens
    • symptoms 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

    CareOne

    NO-RUB CALAMINE SPRAY

    Calamine 8%/ Skin Protectant

    Pramoxine HCl 1%/ External Analgesic

    TEMPORARILY RELIEVES ITCHING FROM POISON IVY, OAK & SUMAC, AND INSECT BITES

    SOOTHES MINOR SKIN IRRITATIONS AND CUTS

    Shake well before use

    NET WT 4.1 OZ (116g)

    Calamine Plus Spray

  • INGREDIENTS AND APPEARANCE
    CALAMINE PLUS PRAMOXINE HCL 
    calamine plus spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-184
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24.16 mg  in 116 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE2.72 mg  in 116 g
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.345 mg  in 116 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISOBUTANE (UNII: BXR49TP611)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-184-41116 g in 1 CANISTER; Type 0: Not a Combination Product02/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/01/2019
    Labeler - Foodhold USA (809183973)
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