GOLDEN SUNSHINE HERBAL- topical analgesic cream

Golden Sunshine Herbal by

Drug Labeling and Warnings

Golden Sunshine Herbal by is a Otc medication manufactured, distributed, or labeled by Golden Sunshine International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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

• simple backache           
  
• arthritis 
  
• strains 
  
• bruises
  
• sprains 

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. 

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

Golden Sunshine® Far Infrared Herbal Cream

INGREDIENTS AND APPEARANCE

GOLDEN SUNSHINE HERBAL 
topical analgesic cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67475-123
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: 67475-123-01	500 g in 1 JAR
2	NDC: 67475-123-02	12 in 1 BOX
2		1 in 1 BOX
2		50 g in 1 TUBE
3	NDC: 67475-123-03	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 - Golden Sunshine International, Inc. (098930857)

Registrant - Golden Sunshine International, Inc. (098930857)

Establishment
Name	Address	ID/FEI	Business Operations
Golden Sunshine International, Inc.		098930857	label