Label: AU KAH CHUEN FUGICAL- calamine and diphenhydramine hydrochlorid cream

  • NDC Code(s): 69070-306-01
  • Packager: Zhejiang Dingtai Pharmaceutical Co., Ltd
  • 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 10, 2019

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  • ACTIVE INGREDIENT

    Active ingredient
    Calamine 10%
    Diphenhydramine hydrochloride 2%

  • PURPOSE

    Purpose
    Skin protectant
    External analgesic

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of pain, itching, and rushes due to:
    poison ivy
    poison oak
    poison sumac

    Dries the oozing and weeping of:
    poison ivy
    poison oak
    poison sumac

  • WARNINGS

    Warnings
    For external use only

  • WHEN USING

    When using this product

    avoid contact with the eyes

  • STOP USE

    Stop use and ask a doctor if

    conditions worsens
    condition does not improve within 7 days
    symptoms clear up and occur again within a few days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and children 2 years of age or older: Apply liberally to affected area not more than 3 to 4 times daily.
    Children under 2 years: Do not use, consult a doctor

  • STORAGE AND HANDLING

    Other information
    keep tightly sealed

  • INACTIVE INGREDIENT

    Inactive ingredients Alcohol, camphor, ceteth-20, cetostearyl alcohol, light mineral oil, menthol, methylparaben, petrolatum, propylparaben, silicon dioxide and water.

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9am-5pm
    you may also report serious side effects to this phone number

  • PRINCIPAL DISPLAY PANEL

    Au Kah Chuen Fugical Cream
    Calamine 10%
    Diphenhydramine hydrochloride 2%
    External Analgesic and Poison Ivy, Oak, and Sumac Drying Cream
    Net Wt. 0.5 oz (15 g)
    NDC 69070-306-01
    Unitbox-01.jpg

  • INGREDIENTS AND APPEARANCE
    AU KAH CHUEN FUGICAL 
    calamine and diphenhydramine hydrochlorid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69070-306
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION9.95 g  in 100 g
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.05 g  in 100 g
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69070-306-011 in 1 BOX06/10/2019
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/10/2019
    Labeler - Zhejiang Dingtai Pharmaceutical Co., Ltd (420598724)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(69070-306)
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