ITCH RELIEF MEDICATED PADS CVS (PRAMOXINE HCL, ZINC ACETATE) LIQUID [CVS]

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ITCH RELIEF MEDICATED PADS CVS (PRAMOXINE HCL, ZINC ACETATE) LIQUID [CVS]
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NDC 69842-842-03
Set ID 3ea8d699-db55-47bf-ade7-6f3e443dfae5
Category HUMAN OTC DRUG LABEL
Packager CVS
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active ingredient

    Pramoxine  HCl 1%               External Analgesic

    Zinc Acetate 0.1%                 Skin Pretectant

  • Uses

    • Temporarily relieves pain and itching asociated with:
    • rashes due to poison ivy, poison oak or poison sumac.
    • insect bites.
    • minor skin irritation.
    • minor cuts.
    • dries the oozing and weeping of poison ivy, poison oak and poison sumac.
  • Warnings

    For external use only.

    Flammable: Do not use near heat, flame, or while smoking.

    ​​​

    When using this product

    • keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days.
    • symptoms persist for more than 7 days or clear up and occur again with in a few days.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • 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. 
  • Inactive ingredients

    Avena Sativa (Oat) Meal Extract
    Camphor
    Citric Acid
    Diazolidinyl Urea
    Fragrance
    Glycerin
    Hydroxypropyl Methylcellulose
    Methylparaben
    Polysorbate 40
    Propylene Glycol
    Propylparaben
    SD Alcohol 38-B
    Sodium Citrate
    Water

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF MEDICATED PADS  CVS
    pramoxine hcl, zinc acetate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-842
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    OATMEAL (UNII: 8PI54V663Y)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 40 (UNII: STI11B5A2X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-842-0369 g in 1 JAR; Type 0: Not a Combination Product03/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/15/2017
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(69842-842)
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