Label: CLEAR ANTI ITCH- pramoxine hydrochloride and zinc acetate lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

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

  • Active Ingredients

    Pramoxind HCl 1%

    Zinc acetate 0.1%

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  • Purpose

    External analgesic

    Skin protectant

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  • Use

    • for the temporary relief oc pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak or poison sumac
    • dries the oozing and weeping of poison: 
    • ivy
    • oak
    • sumac
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  • Warnings

    For external use only

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  • when using this product

    do not get into eyes

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  • 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
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  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • shake well
    • before applying was affected are of skin

    adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily

    children under 2 years of age - ask a doctor

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  • other information

    store at room temperature (59°-77°F)

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  • Inactive ingredients

    alcohol , camphor, citric acid, diazolidinyl urea, fragrance, glycerin, hypromellose, methylparaben, oil of lavender, oil of rosemary, polysorbate 40, propylene glycol, propylparaben, purified water, sodium citrate

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  • questions or comments?

    1-800-632-6900

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  • Adverse reactions

    DISTRIUBTED BY THE KROGER CO

    CINCINNATI, OHIO 45202

    www.kroger.com

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  • disclaimer

    Caladryl Clear is a registered trademark of Johnson + Johnson, Stillman, NJ 08558.  Johnson + Johnson is not affilaed with The Kroger Co. or this product.

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  • Principal Display Panel

    COMPARE TO the active ingredients of

    CALADRYL CLEAR LOTION  see back panel

    Kroger

    FROM OUR FAMILY TO YOURS

    Clear

    anti-itch lotion

    • External Analgesic/Skin Protectant
    • Drying Action Plus Itch Relief

    6 FL OZ (177 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    CLEAR ANTI ITCH 
    pramoxine hcl, zinc acetate lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-218
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 mL
    ZINC ACETATE (ZINC CATION) ZINC CATION 1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    CAMPHOR (NATURAL)  
    CITRIC ACID MONOHYDRATE  
    DIAZOLIDINYL UREA  
    GLYCERIN  
    HYPROMELLOSES  
    METHYLPARABEN  
    LAVENDER OIL  
    ROSEMARY OIL  
    POLYSORBATE 40  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    WATER  
    SODIUM CITRATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-218-30 177 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 03/01/1994
    Labeler - Kroger Co (006999528)
    Registrant - Vi-Jon Inc (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon, Inc 790752542 manufacture(30142-218)
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