Label: ANTI ITCH CREAM - diphenhydramine hydrochloride and zinc acetate cream 

  • Label RSS
  • NDC Code(s): 51141-0054-1, 51141-0054-2
  • Packager: NeoPharm Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/10

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  • Active ingredients (in each gram)

    Diphenhydramine HCl 2%

    Zinc acetate 0.1%

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  • Purposes

    Topical analgesic

    Skin protectant

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  • 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
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  • 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

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  • 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
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  • Other information

    • store at 59° to 77°F
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  • 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

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  • Package label

    Anti-Itch Creamimage of a carton label

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  • INGREDIENTS AND APPEARANCE
    ANTI ITCH CREAM 
    diphenhydramine hcl, zinc acetate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51141-0054
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 2 g  in 100 g
    ZINC ACETATE (ZINC) ZINC ACETATE 0.1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER HOMOPOLYMER TYPE C  
    CETYL ALCOHOL  
    GLYCERIN  
    GLYCERYL MONOSTEARATE  
    PARAFFIN  
    METHYLPARABEN  
    GLYCERYL MONOSTEARATE  
    STEARIC ACID  
    PROPYLPARABEN  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51141-0054-2 1 in 1 BOX
    1 57 g in 1 TUBE
    2 NDC:51141-0054-1 1 in 1 BOX
    2 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 09/07/2010
    Labeler - NeoPharm Co., Ltd. (631101883)
    Registrant - NeoPharm Co., Ltd. (631101883)
    Establishment
    Name Address ID/FEI Business Operations
    NeoPharm Co., Ltd. 631101883 manufacture
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