Label: SUNMARK PHENOLATED CALAMINE- calamine and zinc oxide and phenol lotion

  • NDC Code(s): 49348-802-34
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Calamine 8%

  • Purpose

    Skin Protectant

  • Active Ingredient

    Zinc Oxide 8%

  • Purpose

    Skin Protectant

  • Active Ingredient

    Liquefied Phenol

  • Purpose

    Topical Analgesic

  • Uses

    Dries the oozing and weeping and temporarily pain and itching of poison ivy, poison oak, and poison sumac, or other minor skin irritations

  • Warnings

    • For external use only. Use only as directed.
    • Avoid contact with eyes and mucous membranes.
    • Do not apply to large areas of the body or in large quantities, particularly over raw or blistered areas.
    • If applied to fingers or toes do not bandage.
  • Ask a doctor

    before using on children under 2 years of age.

    When using this product. Discontinue use if condition worsen or does not improve within 7 days and consult a doctor.

  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a poison Control Center immediately.

  • directions (Shake well before using)

    Adult and children 2 years of age and older: Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using cotton or soft cloth, as often as needed for comfort.

    Children under 2 years of age: Consult a doctor before use.

  • Other Information.

    Store at room temperature 15-30C (59-86F)

  • Inactive Ingredients.

    Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water.

  • Principal Display Panel

    Label

    image description

  • INGREDIENTS AND APPEARANCE
    SUNMARK PHENOLATED CALAMINE 
    calamine and zinc oxide and phenol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-802
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION160 mg  in 1 mL
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL10 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:49348-802-34177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01603/25/1998
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114analysis(49348-802) , manufacture(49348-802) , pack(49348-802) , label(49348-802)
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