Label: GOLDEN SUNSHINE HERBAL - topical analgesic cream

  • NDC Code(s): 62699-1123-1, 62699-1123-2, 62699-1123-3
  • Packager: Nan Mei Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 14, 2010

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients
    Menthol 2% - Topical Analgesic, Wintergreen Oil 0.5% - Topical Analgesic

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  • PURPOSE

    Indications
    For the temporary relief of minor aches of muscles and joints associated with:

    • simple backache           
    • arthritis 
    • strains 
    • bruises
    • sprains 
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  • WHEN USING

    Directions
    Apply to affected area not more than 2 to 3 times daily.  Try on small area first to test for
    sensitivity.  Children under 4 years of age should not use, unless consulted by a physician. 

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  • STOP USE

    Warnings

    •     FOR EXTERNAL USE ONLY.
    •     Avoid contact with eyes or mucous membranes.
    •     Do not apply to wounds or damaged or irritated skin.
    •     Do not use if skin is sensitive, or have allergies to any ingredients in this product. Discontinue use and consult a doctor if signs of irritation or rash appear.
    •     In case of ingestion, seek professional assistance or contact a Poison Control Center immediately.
    •     If pregnant or breast feeding consult a doctor before use.
    •     Keep out of reach of children.

    Inactive Ingredients

    Sesame oil, paeonia veitchii radix, angelicae sinensis radix, carthami flos, pyrtum, draconis resina, myrrha, ligustici rhizoma, acanthopanacis cortex, achyranthis radix, atractylodis rhizoma, gerntiane macrophyllae radix, pinelliae tuber, saussureae radix, cnidii monnieri fructus, cinnamonomi cortex, dioscoreae tokoro rhizoma, jasmine oil, tourmaline

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  • QUESTIONS

    For Questions or Comments Call: 1 (800) 798-3977

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  • PRINCIPAL DISPLAY PANEL

    Golden Sunshine® Far Infrared Herbal CreamGolden Sunshine Herbal Cream Sleeve for 50g Tube

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  • INGREDIENTS AND APPEARANCE
    GOLDEN SUNSHINE HERBAL 
    topical analgesic cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62699-1123
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol .02 g  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (Methyl Salicylate - UNII:LAV5U5022Y) METHYL SALICYLATE .005 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Sesame Oil (UNII: QX10HYY4QV) .749 g  in 1 g
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) .04 g  in 1 g
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG) .02 g  in 1 g
    SAFFLOWER (UNII: 4VBL71TY4Y) .02 g  in 1 g
    DRAGON'S BLOOD (UNII: M3YJ2C28IC) .02 g  in 1 g
    MYRRH (UNII: JC71GJ1F3L) .02 g  in 1 g
    LOVAGE OIL (UNII: 7534M4PQ6U) .015 g  in 1 g
    ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB) .01 g  in 1 g
    ACHYRANTHES BIDENTATA ROOT (UNII: 5QIU26R6P1) .01 g  in 1 g
    ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O) .01 g  in 1 g
    GENTIANA LUTEA ROOT (UNII: S72O3284MS) .006 g  in 1 g
    ZEDOARY (UNII: 123C43G128) .006 g  in 1 g
    CNIDIUM SEED (UNII: V1IA3S3CUS) .006 g  in 1 g
    CHINESE CINNAMON BARK (UNII: WS4CQ062KM) .006 g  in 1 g
    DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8) .006 g  in 1 g
    Jasmine Oil (UNII: 9UJS9GG96Y) .005 g  in 1 g
    IRON (UNII: E1UOL152H7) .02 g  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62699-1123-1 500 g in 1 JAR
    2 NDC:62699-1123-2 12 in 1 BOX
    2 1 in 1 BOX
    2 50 g in 1 TUBE
    3 NDC:62699-1123-3 3 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 06/15/2010
    Labeler - Nan Mei Pharmaceutical Co., Ltd. (656348505)
    Registrant - Nan Mei Pharmaceutical Co., Ltd. (656348505)
    Establishment
    Name Address ID/FEI Business Operations
    Nan Mei Pharmaceutical Co., Ltd. 656348505 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Golden Sunshine International, Inc. 098930857 label
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