Label: ATOPALM ITCH RELIEF- diphenhydramine hydrochloride, 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 June 5, 2015

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  • Active Ingredient

    Diphenhydramine HCl 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.

    Do not use

    on large areas of the body or with any other product containing Diphenhydramine, even one taken by mouth.

    Ask a doctor before use on chicken pox or 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 if 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 immediately.

  • Directions

    adults and children 2 years of age and older, apply to affected area no more than 3 to 4 times daily, or as directed by a doctor.
    children under 2 years of age, consult a doctor.
    do not use more often than directed

  • Other information

    store between 20C to 25C (69F to 77F)
    see end of carton or tube crimp for lot number and expiration date.

  • Inactive Ingredients

    Water, Glycerin, Cetyl Alcohol, Mineral Oil, Polysorbate 60, Stearic Acid, Glyceryl sterate, Carbomer 940, Cholesterol, Methylparaben, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, propylparaben.

  • Questions?

    Call 1-855-ATOPALM

  • PRINCIPAL DISPLAY PANEL

    ATOPALM ITCH RELIEF CREAM

    with US Patented MLE Technology


    MAXIMUM STRENGTH THERAPY
    TOPICAL ANALGESIC

    HISTAMINE BLOCKER
    SKIN PROTECTANT

    For fast, temporary relief of pain and itching from insect bites and skin irritations from poison ivy, poison oak, and poison sumac, dries up poison ivy, poison oak, and poison sumac. Leaves skin looking visibly healthier, softer, smoother.

    ATOPALM
    Histamine Blocker
    Topical Analgesic
    Skin protectant

    Net Wt. 1oz/28.3 g

  • PRINCIPAL DISPLAY PANEL

    ATOPALM1

  • PRINCIPAL DISPLAY PANEL

    ATOPALM

  • INGREDIENTS AND APPEARANCE
    ATOPALM ITCH RELIEF  
    diphenhydramine hydrochloride, zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-4000
    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 CATION - UNII:13S1S8SF37) ZINC ACETATE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-4000-11 in 1 BOX
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/16/2011
    Labeler - Neopharm Co, Ltd (965502912)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeoPharm Co., Ltd.631101883manufacture(51141-4000)
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