Label: ITCH RELIEF GEL gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 23, 2020

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

View All Sections
  • DOSAGE & ADMINISTRATION

    Do not use more often than directed.

    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.

  • WARNINGS

    For external use only.

  • INACTIVE INGREDIENT

    Camphor, Citric Acid, Diazolidnyl Urea, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Propylene Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Purified Water.

  • INDICATIONS & USAGE

    Temporarily relieves pain due to: Minor burns, insect bites, sunburn, minor skin irritation, minor cuts, scrapes, rashes due to poison ivy, poison oak and poison sumac.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • PURPOSE

    External Analgesic

  • ACTIVE INGREDIENT

    Diphenhydramine HCl 2%

  • Equate Label

    itchgel [

  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF GEL 
    itch relief gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9134
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-9134-94118 mL in 1 CONTAINER; Type 0: Not a Combination Product12/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/20/2018
    Labeler - Humco Holding Group, Inc (825672884)
    Registrant - Humco Holding Group, Inc (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc825672884manufacture(0395-9134) , label(0395-9134) , pack(0395-9134) , analysis(0395-9134)
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!