Your browser does not support JavaScript! GOLDEN SUNSHINE FAR INFRARED HERBAL (TOPICAL ANALGESIC) PASTE [GOLDEN SUNSHINE INTERNATIONAL, INC.]
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GOLDEN SUNSHINE FAR INFRARED HERBAL (topical analgesic) paste
[Golden Sunshine International, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

Topical Analgesic

Active Ingredients

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

Indications

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

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

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.

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.

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.

For Questions or Comments Call:

1 (800) 798-3977

Golden Sunshine Far Infrared Herbal Paste 1200g Jar Label

GS Herbal Paste 1200g.jpg

GOLDEN SUNSHINE FAR INFRARED HERBAL 
topical analgesic paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67475-211
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL.03 g  in 1 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorblackScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67475-211-011200 g in 1 JAR
2NDC:67475-211-02300 g in 1 JAR
3NDC:67475-211-03450 g in 1 JAR
4NDC:67475-211-0435 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/23/2009
Labeler - Golden Sunshine International, Inc. (098930857)
Registrant - Golden Sunshine International, Inc. (098930857)
Establishment
NameAddressID/FEIBusiness Operations
Golden Sunshine International, Inc.098930857label(67475-211)

Revised: 4/2013
 
Golden Sunshine International, Inc.

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