Label: ASTONEA EXTRA STRENGTH ANTI-ITCH CREAM ITCH STOPPING- diphenhydramine hydrochloride and zinc acetate cream

  • NDC Code(s): 77338-215-01
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 27, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Diphenhydramine hydrochloride 2%Topical analgesic
    Zinc acetate 0.1%Skin protectant
  • Uses

    • temporarily relieves pain and itching associated with:
      • insect bites
      • minor burns
      • sunburn
      • minor skin irritations
      • minor cuts
      • scrapes
      • minor skin irritations
      • rashes due to poison ivy, poison oak, oak, and 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
    • with any other product containing diphenhydramine, even one taken by mouth

    Ask a doctor before use

    • on chicken pox
    • on measles

    When using this product

    • use only as directed
    • avoid contact with eyes

    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. (1-800-222-1222)

  • Directions

    • adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a physician
  • Other information

    • store at 20°C-25°C (68°C/77°F)
    • do not use if tube seal under cap is broken
  • Inactive ingredients

    Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Edetate disodium, Light Mineral Oil, Petrolatum, Propylene Glycol, Sodium metabisulsulfite, Water

  • ASTONEA Extra Strength Anti-Itch Cream

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    ASTONEA EXTRA STRENGTH ANTI-ITCH CREAM  ITCH STOPPING
    diphenhydramine hydrochloride and zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-215
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CHLOROCRESOL (UNII: 36W53O7109)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    CETETH-20 (UNII: I835H2IHHX)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-215-011 in 1 CARTON09/01/2021
    135.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/01/2021
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
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