FAMILY WELLNESS (BENZOCAINE, RESORCINOL) CREAM [ZHEJIANG JINGWEI PHARMACEUTIC AL CO., LTD.]

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FAMILY WELLNESS (BENZOCAINE, RESORCINOL) CREAM [ZHEJIANG JINGWEI PHARMACEUTIC AL CO., LTD.]
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NDC 55621-016-01
Set ID df540eb8-6773-4647-9cc2-c3fd14d7355e
Category HUMAN OTC DRUG LABEL
Packager Zhejiang Jingwei Pharmaceutic Al Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART348
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  • ACTIVE INGREDIENT

    Active ingredients

    Benzocaine  20%

    Resorcinol  3%

  • PURPOSE

    Purpose

    External Analgesic

    External Analgesic

  • INDICATIONS & USAGE

    Uses temporarily relieves itching

  • WARNINGS

    Warnings For external use only.

    When using this product avoid contact

    with the eyes.

    Stop use and ask a doctor if condition

    worsens, or if symptoms persists for

    more than 7 days or clear up and occur

    again within a few days.

    Do not apply over large areas of the body.

  • 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 12 years and older:

    apply a fingertip amount (approximately

    1 inch strip) to the affected area not

    more than 3 to 4 times daily.

    •Children udner 12 years: ask a doctor

  • STORAGE AND HANDLING

    Other information

    Atore at 20° -  25°  C (68° -  77° F).

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe barbadensis leaf juice,

    Cetyl alcohol, Cholecalciferol,

    EDTA, Fragrance, Glyceryl

    stearate, Isopropyl myristate,

    Isopropyl palmitate, Lanolin,

    Methylparaben, Mineral Oil,

    Petrolatum, Propylene glycol,

    Retinol, Sodium lauryl sulfate,

    Sodium Sulfate, Tocopherol,

    Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS 
    benzocaine, resorcinol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    RETINOL (UNII: G2SH0XKK91)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55621-016-011 in 1 CARTON08/20/2017
    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 finalpart34808/20/2017
    Labeler - Zhejiang Jingwei Pharmaceutic Al Co., Ltd. (530876549)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Jingwei Pharmaceutic Al Co., Ltd.530876549manufacture(55621-016)
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