GOLDEN SUNSHINE FAR INFRARED HERBAL- topical analgesic paste

Golden Sunshine Far Infrared Herbal by

Drug Labeling and Warnings

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

Drug Details [pdf]

PURPOSE

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

INGREDIENTS AND APPEARANCE

GOLDEN SUNSHINE FAR INFRARED HERBAL 
topical analgesic paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67475-211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.03 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	.03 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SESAME OIL (UNII: QX10HYY4QV)	.731 g  in 1 g
PINUS MASSONIANA RESIN (UNII: 64S07U83T7)	.1 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z)	.03 g  in 1 g
SCHORL TOURMALINE (UNII: 173O8XLY6T)	.01 g  in 1 g
AMPELOPSIS JAPONICA ROOT (UNII: O2672197TF)	.005 g  in 1 g
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)	.005 g  in 1 g
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)	.005 g  in 1 g
CHINESE CINNAMON (UNII: WS4CQ062KM)	.005 g  in 1 g
MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)	.005 g  in 1 g
PAEONIA VEITCHII ROOT (UNII: VX6GD6M93V)	.005 g  in 1 g
NOTOPTERYGIUM INCISUM ROOT (UNII: 5Z2WW4J6RI)	.005 g  in 1 g
LINDERA AGGREGATA ROOT (UNII: 517Q7XRT2T)	.005 g  in 1 g
GLYCYRRHIZA INFLATA ROOT (UNII: 1MV1Z7MKVQ)	.005 g  in 1 g
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)	.005 g  in 1 g
SCROPHULARIA NINGPOENSIS ROOT (UNII: HC0FB6P85R)	.005 g  in 1 g
RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M)	.005 g  in 1 g
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)	.005 g  in 1 g
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)	.005 g  in 1 g
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)	.0001 g  in 1 g
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	.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; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	02/23/2009
2	NDC: 67475-211-02	300 g in 1 JAR; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	02/23/2009
3	NDC: 67475-211-03	450 g in 1 JAR; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	02/23/2009
4	NDC: 67475-211-04	35 g in 1 JAR; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	02/23/2009

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)