Label: BLISTEX IVAREST POISON IVY ITCH- zinc acetate and pramoxine hydrochloride 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 December 14, 2021

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Pramoxine HCl 1.0% (w/w)External Analgesic
    Zinc Acetate 0.12 % (w/w)Skin Protectant
  • Uses

    • for the temporary relief of pain and itching associated with poison ivy, poison oak, poison sumac, insect bites or minor skin irritations.
    • dries the oozing and weeping of poison:
      • ivy
      • oak
      • sumac
  • Warnings

    For external use only

    Do not use

    • on large areas of the body

    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

    • do not use more often than directed.
    • as soon as possible after exposure, wash affected area with soap and water. Gently pat dry.
    • apply Ivarest Poison Ivy Itch Spray liberally.
    • wash hands after use.
    • adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily.
    • children under 2 years of age: consult a doctor.
  • Inactive ingredients

    glycerin, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, purified water, SD alcohol 38-B, sodium citrate

  • PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

    Quick Relief Spray

    MAXIMUM STRENGTH
    IVAREST®
    EXTERNAL ANALGESIC/SKIN PROTECTANT

    POISON IVY
    ITCH SPRAY

    Also Great For
    Insect Bites!

    No Rub,
    No Mess
    Stays Where You Spray It
    To Protect Affected Area

    Soothes
    Skin Fast
    Relieves Itch and Pain,
    Comforts Irritated Skin

    Poison Ivy, Oak & Sumac,
    Insect Bites, Minor Skin Irritations

    Net 3.4 fl oz. (100 mL)

    PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    BLISTEX IVAREST POISON IVY ITCH 
    zinc acetate and pramoxine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-2100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Acetate (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) Zinc Acetate0.12 g  in 100 mL
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Glycerin (UNII: PDC6A3C0OX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-2100-1100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/02/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34702/02/2015
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-2100)
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!