ITCH RELIEF GEL (DIPHENHYDRAMINE HCL) GEL [WALGREENS]

ITCH RELIEF GEL (DIPHENHYDRAMINE HCL) GEL [WALGREENS]
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NDC 0363-0353-04
Set ID 487060a7-dff3-4840-b967-ca919f8d0a29
Category HUMAN OTC DRUG LABEL
Packager Walgreens
Generic Name
Product Class
Product Number
Application Number PART348
  • Active ingredient

    Diphenhydramine HCL 2%

  • Purpose

    Topical Analgesic

  • Use

    Temporarily relieves pain and itching associated with: insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, rashes due to poison ivy, poison oak, and poison sumac

  • Warnings

    For external use only.

  • Do not use:

    on large areas of the body,

    with any other product containing diphenhydramine, even one taken by mouth

  • Ask a doctor before use 

    on chicken pox,

    on measles

  • When using this product

    avoid contact with eyes

  • Stop use and ask a doctor if

    condition worsens, symptoms persist for 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 than directed.

    Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

  • Other information

    Store at room temperature

  • Inactive ingredients

    camphor, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, purified water, SD alcohol 40-B, sodium citrate

  • Questions?

    1-800-925-4733

  • Directions

    Apply to affected area not more thatn 3 to 4 times daily

  • Tube label

    Tube labelTube labelTube labelTube label

  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF GEL 
    diphenhydramine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0353
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2.03 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R) 47.12 g  in 100 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 42.5 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 4 g  in 100 g
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 0.5 g  in 100 g
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 0.20 g  in 100 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 0.20 g  in 100 g
    PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.10 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) .50 g  in 100 g
    alcohol (UNII: 3K9958V90M) 2.00 g  in 100 g
    HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2) .75 g  in 100 g
    Product Characteristics
    Colorwhite (clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0353-04120.06 g in 1 TUBE; Type 0: Not a Combination Product05/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/30/2018
    Labeler - Walgreens (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(0363-0353)

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