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

  • NDC Code(s): 72476-218-30
  • Packager: Retail Business Services, LLC
  • 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 April 24, 2023

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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 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

  • SPL UNCLASSIFIED SECTION

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

    DISTRIBUTED BY

    ADUSA DISTRIBUTION, LLC

    SALISBURY, NC 28147

    1-833-992-3872

    Quality guaranteed or your money back.

  • Principal display panel

    CAREONE

    Clear Anti-Itch Lotion

    EXTERNAL ANALGESIC/

    SKIN PROTECTANT

    Drying Action

    Plus Itch Relief

    PRAMOXINE HCl 1%

    ZINC ACETATE 0.1%

    Compare to the active ingredents of Caladryl Clear Lotion*

    6 FL OZ (177mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CLEAR ANTI-ITCH 
    pramoxine hcl, zinc acetate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-218
    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 ACETATE1.0 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:72476-218-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34703/22/2016
    Labeler - Retail Business Services, LLC (967989935)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(72476-218)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(72476-218)
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