Label: A HEALTH ITCH RELIEF GEL- itch relief gel gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • 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%

  • PRINCIPAL DISPLAY PANEL

    a health itch gelHealth Itch Relief 2022

  • INGREDIENTS AND APPEARANCE
    A HEALTH ITCH RELIEF GEL 
    itch relief gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-376
    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
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69452-376-55118 mL in 1 CONTAINER; Type 0: Not a Combination Product11/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/08/2022
    Labeler - Bionpharma, Inc. (079637826)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(69452-376) , label(69452-376) , pack(69452-376) , analysis(69452-376)
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