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

  • 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 August 8, 2022

If you are a consumer or patient please visit this version.

  • 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, camphor, citric acid, diazolidinyl urea, fragrance, glycerin, hypromellose, methylparaben, oil of lavender, oil of rosemary, polysorbate 40, propylene glycol, propylparaben, purified water, sodium citrate

  • Adverse reaction

    Visit us at: Rexall.com or call 1-866-4-REXALL

    DISTRIBUTED BY OLD EAST MAIN CO.

    100 Mission Ridge

    Goodlettsville, TN 37072 

    Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc

    A0154

  • principal display panel

    Since 1903

    Rexall

    Clear Antio-Itch Lotion

    External Analgesic Skin Protectant

    For relief from pain and itcing due  to:

    • Poison ivy, oak and sumac
    • Insect bites
    • Minor skin irritations

    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:55910-218
    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)  
    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:55910-218-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34706/30/2011
    Labeler - DOLGENCORP, LLC (068331990)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55910-218)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55910-218)