DUANE READE ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [DUANE READE]

DUANE READE ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [DUANE READE]
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NDC 24488-035-18
Set ID 5cd87150-405d-4d13-b975-111e3f1f9236
Category HUMAN OTC DRUG LABEL
Packager Duane Reade
Generic Name
Product Class
Product Number
Application Number PART336
  • Active Ingredient

    Diphenhydramine hydrochloride 2%........Topical analgesic
    Zinc acetate 0.1%.......Skin protectant

  • Uses

    • temporarily relieves pain and itching associated with:
    • insect bites  
    • minor burns  
    • sunburn
    • minor skin irritations
    • minor cuts
    • scrapes
    • rashes due to poison ivy, poison oak, and poison sumac
    • dries the oozing and weeping of 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 or does not improve within 7 days
    • 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 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
  • Other information

    • To open: unscrew cap, use pointed end of cap to puncture seal.
    • store at room temperature
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    purified water aqua/eau; cetyl alcohol; glyceryl stearate; peg-100 stearate; propylene glycol; sodium polyacrylate and ethylhexyl stearate and trideceth-6; methylparaben; propylparaben

  • Questions

    Call 1-866-923-4914

  • PRINCIPAL DISPLAY PANEL

    placeholder text

    anti-itch_cream2percent_1oz_label
  • INGREDIENTS AND APPEARANCE
    DUANE READE  ANTI-ITCH
    diphenhydramine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (PHENOL - UNII:339NCG44TV) DIPHENHYDRAMINE HYDROCHLORIDE.568 g  in 28.4 g
    ZINC ACETATE ANHYDROUS (UNII: H2ZEY72PME) (ZINC - UNII:J41CSQ7QDS) ZINC ACETATE ANHYDROUS.284 g  in 28.4 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-035-181 in 1 BOX
    128.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33602/01/2011
    Labeler - Duane Reade (961956229)
    Registrant - Creations Garden Natural Products Inc. (961956229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creations Garden Natural Products Inc.961956229manufacture

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