XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]

XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]
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NDC 58503-052-01, 58503-052-02
Set ID a76f6abe-37cf-459f-96e3-7dd60b6d5723
Category HUMAN OTC DRUG LABEL
Packager China Ningbo Shangge Cosmetic Technology Corp
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active Ingredients:                                 Purpose

    Menthol 1.25% ........................... Topical Analgesic

  • PURPOSE

    Uses

    for the temporary relief of minor aches and pains of muscles and joints.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    XtraCare® Ice Cold Topical Analgesic Gel

    Net Wt 8 oz (227 g)

  • WARNINGS

    Warnings

    For external use only. Avoid contact with eyes.

    Ask a doctor before use if you have cough associated with

    • smoking
    • excessive phlegm
    • asthma
    • emphysema
    • persistent or chronic cough

    When using this product do not

    • heat
    • microwave
    • add to hot water or any container where heating water may cause splattering and result in burns
    • use in eyes or directly on mucous membranes
    • take by mouth or place in nostrils
    • apply to wounds or damaged skin
    • bandage skin

    Consult a doctor and discontinue use if condition worsens, persists for more than 1 week or tends to recur.

  • DOSAGE & ADMINISTRATION

    Directions

    • see important warnings under "When using this product"
    • adults & children 2 years of age & older: apply to the affected area not more than 3 to 4 times daily.
    • children under 2 years of age: consult a physician
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    camphor, carbomer, ethyl alcohol, FD&C blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.

  • OTHER SAFETY INFORMATION

    Other information: store at 20o to 25oC (68o to 77oF)

    Questions/Comments? 1-855-345-5575

    DISTRIBUTED BY:

    REJOICE INTERNATIONAL INC

    NORTHVILLE, MI 48168 USA

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    label image

    tube image

  • INGREDIENTS AND APPEARANCE
    XTRACARE ICE COLD TOPICAL ANALGESIC GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 227 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-052-01227 g in 1 BOTTLE; Type 0: Not a Combination Product01/30/2014
    2NDC:58503-052-02227 g in 1 TUBE; Type 0: Not a Combination Product01/30/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/30/2014
    Labeler - China Ningbo Shangge Cosmetic Technology Corp (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-052)

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