Label: ANTI ITCH- diphenhydramine hcl, zinc acetate cream

  • NDC Code(s): 67510-0054-1, 67510-0054-2
  • Packager: Kareway Product, Inc.
  • 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 15, 2023

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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

    Cetyl alcohol, Glycerin, Glyceryl monostearate, levelling agent0, liquid paraffin, methylparaben, octadecyl alcohol, propyl 4-hydroxybenzoate, propylene glycol, purified water, stearic acid, vaseline

  • Package label

    Anti-Itch Cream

    carton

  • INGREDIENTS AND APPEARANCE
    ANTI ITCH 
    diphenhydramine hcl, zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.1 g  in 100 g
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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:67510-0054-21 in 1 BOX08/11/2011
    157 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:67510-0054-11 in 1 BOX08/11/2011
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/11/2011
    Labeler - Kareway Product, Inc. (121840057)
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