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 January 14, 2019

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

  • ACTIVE INGREDIENT

    Pramoxine HCl 1%

    Zinc Acetate 0.1%

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  • PURPOSE

    External Analgesic & Skin Protectant

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  • 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

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  • 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.

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  • 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)

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  • 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.

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  • INACTIVE INGREDIENT

    SD Alcohol 38B 2.5%

    Camphor

    Diazolidinyl Usea

    Fragrances

    Glycerin

    Hydroxypropyl Methylcellulose

    Methylparaben

    Polysorbate 80

    Propylene Glycol

    Propylparaben

    Purified Water

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  • INGREDIENTS AND APPEARANCE
    CALAMINE CLEAR 
    pramoxine hydrochloride and zinc acetate lotion lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0397
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 mL
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE 1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70000-0397-1 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/15/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 01/15/2019
    Labeler - Cardinal Health (097537435)
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