Label: LEADER CALAMINE PLUS- zinc oxide lotion lotion

  • NDC Code(s): 70000-0400-1
  • Packager: Cardinal Health, 110 dba Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 22, 2023

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  • WARNINGS

    • For external use only
    • Avoid contact with eyes and mucous membranes
    • Ask a doctor before using on children under 2 years of age
  • ACTIVE INGREDIENT

    Calamine 8%

    Pramoxine HCl 1%

  • PURPOSE

    • Skin Protectant
    • External Analgesic
  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age and older: Shake well before using. CLeanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton of soft cloth, not more than 3 to 4 times daily as needed for comfort.

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

  • INACTIVE INGREDIENT

    SH Alcohol 38B 2.5%

    Camphor

    Diazolidinyl Urea

    Fragrances

    Glycerin

    Hydroxypropyl Methylcellulose

    Methylparaben

    Polysorbate 80

    Propylene Glycol

    Propylparabaren

    Purified water

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

  • INDICATIONS & USAGE

    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
  • PRINCIPAL DISPLAY PANEL

    calamineplus

  • INGREDIENTS AND APPEARANCE
    LEADER CALAMINE PLUS 
    zinc oxide lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80 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 (SYNTHETIC) (UNII: 5TJD82A1ET)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0400-1177 mL in 1 CONTAINER; Type 0: Not a Combination Product02/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01602/15/2019
    Labeler - Cardinal Health, 110 dba Leader (063997360)
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