CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC]

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CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC]
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NDC 36800-336-30
Set ID f08cf654-d884-4e12-b008-4caf7d9d33e2
Category HUMAN OTC DRUG LABEL
Packager Topco associates LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active ingredients

    Calamine 8%

    Pramoxind HCl 1%

  • Purpose

    Skin protectant

    External analgesic

  • Use

    • for the temporary relief of pain and itching associated with minot skin irritations and rashes due to poison ivy, poison oak, or poison sumac
    • dries the oozing and weeping of poison:
    • ivy
    • oak
    • sumac
  • Warnings

    For external use only

  • When using this product

    • do not get into eyes
  • Stop use and ask a doctor

    • condition worsens
    • symptoms last more than 7 days or clean up and occur again within 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 applying was affected are of skin

    Adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily

    Children under 2 years of age - do not use, ask a doctor

  • Other information

    store at room temperature (59°-77°F)

  • Inactive ingredients

    alcohol, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, oil of lavender, oil of rosemary, polysorbate 80, propylene glycol, propylparaben, purified water, xanthan gum

  • Dislcaimer

    This product is not manufactured or distributed by Valeant Pharmaceuticals, distributor of Caladryl Lotion

  • Adverse reactions

    DIST. BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL

    @TOPCO VIJA071

    QUESTIONS? 1-888-423-0139

    topcare@topco.coM

    www.topcarebrand.com

    336.002/336AF

  • principal display panel

    TopCare

    Health

    COMPARE TO

    CALADRYL LOTION

    ACTIVE INGREDIENTS

    MEDICATED

    Calamine

    Lotion

    EXTERANAL ANALGESIC/

    SKIN PROTECTANT

    Drying Action Plus

    Itch Relief for:

    Poison Ive, Oak & Sumac

    OUR PHARMACISTS RECOMMEND

    6 FL OZ (177 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CALAMINE 
    calamine, pramoxind hcl lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-336
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED8.6 mg  in 1 mL
    zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z) zinc oxide20 mg  in 1 mL
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-336-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/21/2009
    Labeler - Topco associates LLC (006935977)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(36800-336)
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