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

  • NDC Code(s): 79481-0615-1
  • Packager: Meijer Distribution Inc.
  • 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 August 25, 2023

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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

    meijer

    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)

    image 1

  • INGREDIENTS AND APPEARANCE
    CALAMINE PLUS 
    calamine plus pramoxine hcl aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0615
    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:79481-0615-1116 g in 1 CANISTER; Type 0: Not a Combination Product08/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/25/2023
    Labeler - Meijer Distribution Inc. (006959555)
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