Label: CALADRYL- ferric oxide red, zinc oxide, and pramoxine hydrochloride lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 1, 2020

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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 (831922468)
    Establishment
    NameAddressID/FEIBusiness Operations
    Trillium Health Care Products Inc.255426306MANUFACTURE(0187-5465)
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