GREEN BAMBOO (MENTHOL) CREAM [BALANCE CENTER, INC.]

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GREEN BAMBOO (MENTHOL) CREAM [BALANCE CENTER, INC.]
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NDC 69362-250-01
Set ID 92cfff10-8a5d-4ba9-9da0-81258b91dbbc
Category HUMAN OTC DRUG LABEL
Packager Balance Center, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • ACTIVE INGREDIENTS

    Menthol             5.000%

  • PURPOSE

    External Analgesic

  • USES

    for the temporary relief of minor aches, and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

  • WARNINGS

    -For external use only.

    -Avoid contact with eyes.

    -Do not apply to open wounds or damaged skin.

    -Do not bandage tightly.

  • Keep out of reach of children.

    If swallowed, consult physician.

  • STOP USE

    If symptoms persist for more than seven days, discontinue use and consult physician.

  • ASK DOCTOR

    If pregnant or breast feeding, contact physcian prior to use.

  • DIRECTION

    Apply directly to effected area. Do not use more than four times per day.

  • OTHER INGREDIENTS

    Aqua (Deionized Water), BUTYROSPERMUM PARKII (SHEA) BUTTER, CAMPHOR, CARBOMER, DIAZOLIDINYL UREA, Emulsifying Wax NF, EUCALYPTUS GLOBULUS LEAF OIL, Glyceryl Sterate, HELIANTHUS ANNUUS (SUNFLOWER) Oil, PEG-100 STERATE, POLYSORBATE-20, TRIETHANOLAMINE.

  • GREEN BAMBOO, 113g (69362-250-01)

    GREEN

    BAMBOO

    Net Wt. 4 oz. (113g)

    Distributed by:

    Balance Center

    8704 Rainier Ave. S

    Seattle, WA 89118

    206-380-4294

    Label

  • INGREDIENTS AND APPEARANCE
    GREEN BAMBOO 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69362-250
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69362-250-01113 g in 1 JAR; Type 0: Not a Combination Product02/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/10/2014
    Labeler - Balance Center, Inc. (014572821)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(69362-250)
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