Label: ITCH RELIEF CLEAR SKIN PROTECTANT CVS- pramoxine hcl, zinc acetate spray

  • 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 November 30, 2017

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  • Active ingredient

    Pramoxine  HCl 1%

    Zinc Acetate 0.1%

  • Purpose

    Itch Relief.

  • 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.
    • Do not puncture or incinerate. Contents under pressure. Do no store at temperatures above 120F.

    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

    • shake well before use.
    • 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

    SD Alcohol 38-B, Avena Sative (Oat Meal) Extract, Camphor, Citric Acid, Diazolidinyl Urea, Fragrance, Glycerin, Hypromellose, Methylparaben,Polysorbate 40, Propylene Glycol, Propylparaben, Sodium Citrate, Water.

  • PRINCIPAL DISPLAY PANEL

    CVS Continuous Spray Itch Relief

    Clear Skin Protectant

    1% Pramoxine HCl

    0.1% Zinc Acetate

    image description

  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF CLEAR SKIN PROTECTANT  CVS
    pramoxine hcl, zinc acetate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-295
    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:59779-295-0385 g in 1 CAN; Type 0: Not a Combination Product10/31/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/31/2014
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(59779-295)
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