CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]

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  • CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]

CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]
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NDC 0187-5465-06
Set ID 67d4fd42-9fed-4238-9f5a-c9403abbcf20
Category HUMAN OTC DRUG LABEL
Packager Bausch Health US, LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose

    Calamine 8%

    Skin protectant

    Pramoxine HCl 1%

    Topical analgesic
  • Uses

    •
    temporarily relieves pain and itching associated with:
    •
    rashes due to poison ivy, poison oak 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, xanthan gum

  • Questions/Comments

    call 1-800-321-4576

  • SPL UNCLASSIFIED SECTION

    Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA

    ©2020 Bausch Health Companies Inc. or its affiliates

    Rev. 01/2020

    Made in Canada

  • PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

    Caladryl®

    Topical Analgesic ∙ Skin Protectant
    Lotion

    Calamine Plus Itch Reliever

    6 FL OZ (177 mL)

    label.jpg
  • INGREDIENTS AND APPEARANCE
    CALADRYL 
    ferric oxide red, zinc oxide, and pramoxine hydrochloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-5465
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ferric Oxide Red (UNII: 1K09F3G675) (Ferric Oxide Red - UNII:1K09F3G675) Ferric Oxide Red1.36 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide78.65 mg  in 1 mL
    Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Camphor (Synthetic) (UNII: 5TJD82A1ET)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Methylparaben (UNII: A2I8C7HI9T)  
    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:0187-5465-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/16/2013
    Labeler - Bausch Health US, LLC (831922488)
    Establishment
    NameAddressID/FEIBusiness Operations
    Trillium Health Care Products Inc.255426306MANUFACTURE(0187-5465)
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