Label: CALAMINE- ferric oxide red 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 11, 2021

If you are a consumer or patient please visit this version.

  • Active ingredents

    Calamine 8%
    Zinc oxide 8%

  • Purpose

    Skin Protectant

  • Use

    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 if

    condition worsens
    symptoms last 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 using 
    apply as needed
  • Other information

    store at 59⁰ - 86⁰ F

  • Inactive ingredients

    bentonite magma, calcium hydroxide, glycerin, purified water

  • Questions or comments?

    (800) 616-2471

  • Adverse reactions

    Distributed By:

    MAJOR PHARMACEUTICALS

    17177 N LAUREL PARK DRIVE, SUITE 233

    Livonia, MI 48152

    Re-Order No 014282  M-97

    Rev. 10/16

    063.001/063AA

    Relabeled By: Preferred Pharmaceuticals Inc.

  • Principal Display Panel

    NDC 68788-0902-1

    MAJOR

    Relabeled By: Preferred Pharmaceuticals Inc.

    Calamine

    Lotion

    Calamine Topical Suspension USP

    Skin Protectant

    Poison Ivy, Oak, Sumac

    Drying Lotion

    Shake well before using

    6 FL OZ (177 mL)

    Calamine Lotion
  • INGREDIENTS AND APPEARANCE
    CALAMINE 
    ferric oxide red lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-0292(NDC:0904-2533)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED8 g  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-0292-1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/19/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/19/2018
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-0292)