Label: ANTI-ITCH CREAM- 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 September 20, 2023

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  • Active Ingredients

    Diphenhydramine hydrochloride 2%

    Zinc Acetate 0.1%

  • Purpose

    Topical Analgesic

    Skin Protectant

  • Use

    for temporary relief from pain and itching associated with insect bites, sunburn, and minor skin irritations. Dries the oozing and weeping of poison:

    • ivy
    • oak
    • sumac
  • WARNINGS

    For external use only

  • Do not use

    • over large areas of the body
    • with any other product containing diphenhydramine, including those taken orally
  • When using this product

    • avoid contact with eyes
  • Ask a doctor before use

    • on chicken pox
    • on measles
  • Stop use and ask a doctor if

    • symptoms last for more than 7 days
    • the condition gets worse
    • symptoms clear up and then 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 2 years of age and older: apply to affected area not more than 3 to 4 times per day.
    • children under 2 years of age: ask a doctor before use
  • Inactive ingredients

    cetyl alcohol, glyceryl monostearate, methylparaben, mineral oil, petrolatum, polyoxyethylene lauryl ether, propylene glycol, propylparaben, purified water, stearic acid, stearyl alcohol

  • Questions

    1-800-639-3803 Weekdays 9 AM to 4 PM EST

  • Other information

    • store at room temperature 59 degrees - 77 degrees F (15 degrees - 25 degrees C).
    • tamper-evident: do not use if foil seal is broken or missing.
  • PRINCIPAL DISPLAY PANEL

    Extra Strength

    Anti-Itch Cream

    Topical Analgesic and Skin Protectant Cream

    Net Wt 1 oz (28 g)

    Front Panel

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH CREAM 
    diphenhydramine hcl / zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-011
    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 CATION0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    LAURETH-15 (UNII: 002FR4N8OV)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69571-011-011 in 1 BOX09/25/2023
    128 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 finalpart34809/25/2023
    Labeler - Front Pharmaceutical PLC (530897792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Front Pharmaceutical530897792manufacture(69571-011)
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