Label: CALAMINE CLEAR- pramoxine hydrochloride and zinc acetate lotion 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 March 16, 2022

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  • ACTIVE INGREDIENT

    Pramoxine HCl 1%

    Zinc Acetate 0.1%

  • PURPOSE

    External Analgesic & Skin Protectant

  • INDICATIONS & USAGE

    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. Use only as directed.

    Acoid contact with eyes and mucous membranes

    Ask a doctor before using on children under 2 years of age.

  • 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)

  • 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 fo the affected area using cotton or soft cloth, not more than 3 to 4 times dialy as needed for comfort.

  • INACTIVE INGREDIENT

    SD Alcohol 38B 2.5%

    Camphor

    Diazolidinyl Usea

    Fragrances

    Glycerin

    Hydroxypropyl Methylcellulose

    Methylparaben

    Polysorbate 80

    Propylene Glycol

    Propylparaben

    Purified Water

  • PRINCIPAL DISPLAY PANEL

    calclear

  • INGREDIENTS AND APPEARANCE
    CALAMINE CLEAR 
    pramoxine hydrochloride and zinc acetate lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0397
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0397-1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/15/2019
    Labeler - Cardinal Health, 110 dba Leader (063997360)
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