Label: CLEAR ANTI-ITCH- pramoxine hcl, zinc acetate lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 12, 2024

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  • Active ingredients

    Pramoxine HCl 1%

    Zinc acetate 0.1%

  • Purpose

    External analgesic

    Skin protectant

  • Uses

    • for the temporary relief of 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
  • Warnings

    For external use only

  • When using this product

    • do not get into eyes
  • Stop use section and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
  • Keep out of reach of children.

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

  • Directions

    • shake well
    • before applying wash affected area 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 - ask a doctor

  • Other information

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

  • Inactive ingredients

    alcohol, benzoic acid, camphor, citric acid, fragrance, glycerin, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, polysorbate 40, Rosmarinus officinalis (rosemary) leaf oil, sodium citrate, water

  • Disclaimer

    *This product is not manufactured or distributed by Bausch Health US, LLC, distributor of Caladryl® Clear® Lotion.

  • Adverse reaction

    Distributed by: Perrigo Direct, Inc.

    Peachtree City, GA 30269

    www.PerrigoDirect.com

    1-888-593-0593

    GoodSense is a registed trademark of L. Perrigo Company.

  • Principal Display Panel

    GoodSENSE®

    Clear Anti-Itch Lotion

    External Analgesic/Skin Protectant

    Pain and Itch Reliever

    Compare to active ingredients of Caladryl® Clear® Lotion*

    6 FL OZ (177 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CLEAR ANTI-ITCH 
    pramoxine hcl, zinc acetate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75981-218
    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
    ALCOHOL (UNII: 3K9958V90M)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    POLYSORBATE 40 (UNII: STI11B5A2X)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75981-218-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/24/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/24/2008
    Labeler - Perrigo Direct, Inc. (076059836)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(75981-218)
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