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

  • NDC Code(s): 41250-218-30
  • Packager: Meijer Distribution, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 26, 2022

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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 Valeant Pharmaceuticals, distributor of Caladryl Clear Lotion

  • SPL UNCLASSIFIED SECTION

    Our Quality Guarantee

    WWW.MAIJER.COM/SATISFACTION

     *This product is not manufactured

    or distributed by Bausch Health US,

    LLC, distributer of Caladryl Clear Lotion

    DISTRIBUTED BY MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.miejer.com

  • Principal Panel Display

    NDC 41250-218-30

    Meijer

    Compare to Caladryl Clear Lotion*

    CLEAR

    anti-itch

    lotion

    External Analgesic/Skin Protectant

    Drying Action Plus Itch Relief

    Relieves minor

    skin irritation

    Dries clear

    6 FL OZ ( 177 mL)

    Empty & Replace Cap

    Plastic Bottle

    how2recycle.info

    image description

  • INGREDIENTS AND APPEARANCE
    CLEAR ANTI-ITCH 
    pramoxine hcl, zinc acetate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-218
    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:41250-218-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/02/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34706/02/2009
    Labeler - Meijer Distribution, Inc. (006959555)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(41250-218)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(41250-218)
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