Label: DUANE READE ANTI-ITCH- diphenhydramine hydrochloride cream

  • 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 February 1, 2011

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  • 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

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    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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