Label: DIPHENHYDRAMINE- diphenhydramine hcl, zinc acetate cream

  • 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 August 29, 2011

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  • Active Ingredients

    Diphenhydramine hydrochloride 2%

    Zinc acetate 0.1%

  • Purpose

    Topical Analgesic

    Skin protectant

  • Uses

    • For the temporary relief of itching and pain 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.

  • Ask a doctor before use

    • on chicken pox
    • on measles
  • When using this product

    • avoid contact with the eyes
  • Stop use and ask a doctor if

    condition worsens or does not improve within 7 days, or symptoms persist for more than 7 days or clear up and occur again within a few days.


  • Do not use

    • on large areas of the body
    • with any other product containing diphenhydramine, even one taken by mouth
  • 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, or as directed by a doctor
    • children under 2 years of age, consult a doctor
  • Other information

    • Store between 20o and 25oC (68o to 77oF)
    • Lot no. and Exp. Date: see box or see crimp of tube
    • Keep box for complete instructions and labeling
  • Inactive Ingredients

    cetyl alcohol, diazolidinyl urea, dodecyl-2-N,N-dimethylaminopropionate hydrochloride, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene glycol, propylparaben, purified water

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  • PRINCIPAL DISPLAY PANEL

    Image of Carton and Label
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE   D
    diphenhydramine hcl, zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40002-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 2 g  in 100 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC - UNII:J41CSQ7QDS) ZINC ACETATE .1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Dodecyl-2-N,N-Dimethylaminopropionate Hydrochloride (UNII: 18F5YMF989)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-2 STEARATE (UNII: 94YQ11Y95F)  
    PEG-20 STEARATE (UNII: NBX892EA57)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40002-004-031 in 1 CARTON
    1NDC:40002-004-0228 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/29/2011
    Labeler - NexMed (USA), Inc. (031710528)
    Registrant - NexMed (USA), Inc. (031710528)
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