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

  • NDC Code(s): 55319-941-30
  • Packager: Family Dollar Services, 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 December 8, 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 monor sking irritations and rashed 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, camphor, citric acid, diazolidinyl urea, fragrance, glycerin, hypromellose, methylparaben, oil of lavender, oil of rosemary, polysorbate 40, propylene glycol, propylparaben,purified water, sodium citrate

  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, Distributor of Caladryl Clear Lotion*

    DISTRIBUTED BY:
    FAMILY DOLLAR SERVICES, INC.,
    10401 MONROE RD,
    MATTHEWS, NC 28105 USA
    NOT 100% SATISFIED?
    Return package and unused product within 30 days to any Family Dollar store for a refund ( with receipt) or exchange.

  • principal display panel

    FAMILY Wellness

    COMPARE TO THE ACTIVE INGREDIENTS OF CALADRYL CLEAR LOTION

    100% SATISACTION OR YOUR MONEY BACK GUARANTEED

    Clear Anti-Itch Lotion

    External Analgesic

    Skin Protectant

    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:55319-941
    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)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    POLYSORBATE 40 (UNII: STI11B5A2X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-941-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/16/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34712/16/2015
    Labeler - Family Dollar Services, Inc., (024472631)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55319-941)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55319-941)
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