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

  • 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 April 17, 2020

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

  • 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 was affected are 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, camphor, citric acid, diazolidinyl urea, fragrance, glycerin, hydroxypropyl methylcellulose, 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 Valeant Pharmaceuticals, distributor of Caladryl*

    Manufactured by:

    Vi-Jon
    One Swan Drive
    Smyrna, TN 37167

    DSP-TN-15000

    DSP-MO-34

    SDS-TN-15012

  • principal display panel

    SWAN

    Clear Anti-itch Lotion

    EXTERNAL ANALGESIC

    SKIN PROTECTANT

    For Relief from Pain and Itching due to:

    Poison Ivy, Poison Sumac, Insect Bites, Poison Oak, + Minor Skin Irritatins

    Compare to the active ingredients of Caladryl Clear*

    6 FL OZ (177 mL)

    image description

  • principal display panel

    Mountain Falls

    *Compare to Caladryl

    Clear anti-itch lotion

    external analgesic

    skin protectant

    Drying action plus itch relief

    Relieves 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:0869-0218
    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 (NATURAL) (UNII: N20HL7Q941)  
    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:0869-0218-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/07/1994
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/07/1994
    Labeler - Vi-Jon (790752542)
    Registrant - Vi-Jon Inc (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, Inc790752542manufacture(0869-0218)