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

  • NDC Code(s): 21130-952-30
  • Packager: Better Living Brands LLC
  • 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 November 4, 2022

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  • Active Ingredients

    Pramoxine HCl 1%

    Zinc acetate 0.1%

  • Purpose

    External analgesic

    Skin protectant

  • Use

    • 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 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 of age - 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

  • SPL UNCLASSIFIED SECTION

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

    Scan here for more information 

    Empty Before Recycling PLASTIC BOTTLE 

    how2recycle.info

    DISTRIBUTED BY: BETTER LIVING BRANDS LLC
    P.O. BOX 99
    PLEASANTON, CA 94566-0009
    1-888-723-3929
    LOVE IT

    OR IT'S ON US

  • principal display panel

    NDC 21130-952-30

    Signature Care

    Quality Guaranteed

    CLEAR Anti-Itch Lotion

    Pramoxine HCl 1%

    Zinc Acetate 0.1%

    External Analgesic/Skin Protectant

    Compare to Caladryl Clear Lotion active ingredients*

    Drying action plus itch relief

    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:21130-952
    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 CATION1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    benzoic acid (UNII: 8SKN0B0MIM)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    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:21130-952-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/28/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/28/2009
    Labeler - Better Living Brands LLC (009137209)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(21130-952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(21130-952)
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