Label: ITCH RELIEF MEDICATED PADS CVS- pramoxine hcl, zinc acetate liquid

  • 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

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

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!