Label: GOLDEN SUNSHINE FAR INFRARED HERBAL- menthol and methyl salicylate paste 

  • Label RSS
  • NDC Code(s): 67475-211-01, 67475-211-02, 67475-211-03, 67475-211-04
  • Packager: Golden Sunshine International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

If you are a consumer or patient please visit this version.

  • PURPOSE

    Topical Analgesic

    Close
  • Active Ingredients

    Menthol 3% - Topical Analgesic, Wintergreen Oil 3% - Topical Analgesic

    Close
  • Indications

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

    • simple backache
    • arthritis
    • strains
    • bruises
    • trauma
    • sprains
    Close
  • Directions

    Apply generous amount to clean, dry affected area. Cover with gauze 15-20 hours/day. Try on small area first to test for sensitivity. Children under 6 years of age should not use unless consulted by a physician.

    Close
  • Warnings

    • FOR EXTERNAL USE ONLY

    • Avoid contac 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.
    Close
  • Other Ingredients

    Sesame oil, resin, zinc oxide, tourmaline, amperopsis radix, angelicae dahuricae radix, angelicae sinensis radix, cinnamonomi cortex, momordicae semen, paeonia veitchii radix, notopterygium rhizoma, lindera radix, glycyrrhizae radix, angelica tuhon radix, scrophulariae radix, rhei rhizoma, rehmaniae radix et rhizoma, sophorae radix, indigo carmine, tartrazine.

    Close
  • For Questions or Comments Call:

    1 (800) 798-3977

    Close
  • Golden Sunshine Far Infrared Herbal Paste 1200g Jar Label
  • INGREDIENTS AND APPEARANCE
    GOLDEN SUNSHINE FAR INFRARED HERBAL 
    topical analgesic paste
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67475-211
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL .03 g  in 1 g
    METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE .03 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    SESAME OIL .731 g  in 1 g
    PINUS MASSONIANA RESIN .1 g  in 1 g
    ZINC OXIDE .03 g  in 1 g
    SCHORL TOURMALINE .01 g  in 1 g
    AMPELOPSIS JAPONICA ROOT .005 g  in 1 g
    ANGELICA DAHURICA ROOT .005 g  in 1 g
    ANGELICA SINENSIS ROOT .005 g  in 1 g
    CHINESE CINNAMON .005 g  in 1 g
    MOMORDICA COCHINCHINENSIS SEED .005 g  in 1 g
    PAEONIA VEITCHII ROOT .005 g  in 1 g
    NOTOPTERYGIUM INCISUM ROOT .005 g  in 1 g
    LINDERA AGGREGATA ROOT .005 g  in 1 g
    GLYCYRRHIZA INFLATA ROOT .005 g  in 1 g
    ANGELICA ACUTILOBA ROOT .005 g  in 1 g
    SCROPHULARIA NINGPOENSIS ROOT .005 g  in 1 g
    RHEUM OFFICINALE ROOT .005 g  in 1 g
    REHMANNIA GLUTINOSA ROOT .005 g  in 1 g
    SOPHORA FLAVESCENS ROOT .005 g  in 1 g
    FD&C BLUE NO. 2 .0001 g  in 1 g
    FD&C YELLOW NO. 5 .0001 g  in 1 g
    Product Characteristics
    Color black Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67475-211-01 1200 g in 1 JAR
    2 NDC:67475-211-02 300 g in 1 JAR
    3 NDC:67475-211-03 450 g in 1 JAR
    4 NDC:67475-211-04 35 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 02/23/2009
    Labeler - Golden Sunshine International, Inc. (098930857)
    Registrant - Golden Sunshine International, Inc. (098930857)
    Establishment
    Name Address ID/FEI Business Operations
    Golden Sunshine International, Inc. 098930857 label(67475-211)
    Close