Label: ANTI ITCH CREAM- diphenhydramine hcl, zinc acetate 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 August 29, 2010

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  • Active ingredients (in each gram)

    Diphenhydramine HCl 2%

    Zinc acetate 0.1%

  • Purposes

    Topical analgesic

    Skin protectant

  • Uses

    • temporarily relieves itching and pain associated with insect bites, minor skin irritations and rashes due to poison ivy, poison oak or poison sumac
    • dries the oozing and weeping of poison ivy, poison oak, and poison sumac
  • Warnings

    For external use only

    Do not use

    • on chicken pox or measles
    • with any other product containing diphenhydramine, even one taken by mouth
    • on large areas of the body, including large areas of poison ivy, sunburn, or broken, blistered or oozing skin

    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

    • adults and children 12 years of age and over:  apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age:  ask a doctor
    • do not use more often than directed
  • Other information

    • store at 59° to 77°F
  • Inactive ingredients

    Carbomer 940, Cetyl alcohol, Glycerin, Glyceryl monostearate, Light liquid paraffin, Methylparaben, Myristoyl/palmitoyl oxostearamide/ arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Propylparaben, Purified water

  • Package label

    Anti-Itch Creamimage of a carton label

  • INGREDIENTS AND APPEARANCE
    ANTI ITCH CREAM 
    diphenhydramine hcl, zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC - UNII:J41CSQ7QDS) ZINC ACETATE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-0054-21 in 1 BOX
    157 g in 1 TUBE
    2NDC:51141-0054-11 in 1 BOX
    228 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33609/07/2010
    Labeler - NeoPharm Co., Ltd. (631101883)
    Registrant - NeoPharm Co., Ltd. (631101883)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeoPharm Co., Ltd.631101883manufacture
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