CALAMINE PLUS (FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) AEROSOL, SPRAY [WAL-MART STORES, INC.]

CALAMINE PLUS (FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) AEROSOL, SPRAY [WAL-MART STORES, INC.]
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NDC 49035-030-01
Set ID eba4b13f-bc23-45d5-b01e-8ca10cdbb2cc
Category HUMAN OTC DRUG LABEL
Packager Wal-Mart Stores, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients

    Calamine 8%

    Pramoxine HCL 1%

  • Purpose

    Purpose

    Skin protectant

    External analgesic

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    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

    Warnings

    For external use only. Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

  • Flammable

    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 degrees F.

  • When using this product

    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

    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
  • Directions

    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 to 4 times a day
  • Other information

    Other information

    store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

  • Inactive ingredients

    Inactive ingredients

    benzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate


  • Questions?

    Questions ? Call 1-866-964-0939

  • Principal Display Panel

    Equate

    No-Rub

    Calamine Plus Spray

    Calamine 8%, Pramoxine HCL 1%

    External Analgesic,

    Skin Protectant

    Relieves pain & itching from:

    • Poison Ivy, Oak and Sumac
    • Sprays on pink

    NET WT 4.1 OZ (116 g)

    Calamine Plus Spray

  • INGREDIENTS AND APPEARANCE
    CALAMINE PLUS 
    ferric oxide red, pramoxine hydrochloride, zinc oxide aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-030
    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 1 mL
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE2.72 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24.16 mg  in 1 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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-030-01177 mL in 1 CANISTER; Type 0: Not a Combination Product03/03/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/03/2013
    Labeler - Wal-Mart Stores, Inc. (051957769)

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