CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC]

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CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC]
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NDC 59970-075-01
Set ID 7f2c5adf-92ca-4257-b71b-f7578a481c92
Category HUMAN OTC DRUG LABEL
Packager Navarro Discount Pharmacies, LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active ingredients

    Calamine 8%

    Pramoxine HCl 1%

  • Purpose

    Skin protectant

    Topical analgesic

  • Uses

    temporarily relieves pain and itching associated with:

    • rashes due to poison ivy, poison oac or poison sumac
    • insect bites
    • minor skin irritation
    • minor cuts

    dries the oozing and weeping of poison ivy, poison oak and poison sumac

  • Warnings

    For external use only.

    When using this product

    do not get into eyes

    Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days
    • symptoms persist for more than 7 days or clear 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 use
    • 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: ask a doctor
  • Other information

    • store at 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    SD alcohol 38-B, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, zanthan gum

  • Package Label

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    CALAMINE 
    zinc oxide, ferric oxide red, pramozine hcl lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59970-075
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg  in 1 mL
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED80 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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59970-075-01177 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/03/2013
    Labeler - Navarro Discount Pharmacies, LLC (094930963)
    Registrant - Kareway Product, Inc. (121840057)
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