GOLDEN SUNSHINE FAR INFRARED COOL HERBAL- topical analgesic patch

Golden Sunshine Far Infrared COOL Herbal by

Drug Labeling and Warnings

Golden Sunshine Far Infrared COOL 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 0.5% - Topical Analgesic

Indications

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

• simple backache
• arthritis
• strains
• bruises
• sprains

Directions

For adults and children 6 and older. Clean the affected area before use. Can be cut to size. Peel off film and cover affected area with patch. Keep on for up to 8 hours under normal conditions. Apply once or twice per day as needed. Allow skin to breath for a few hours between applications. Users with sensitive skin should test on a small area first.

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.
• Avoid use on extremely hairy areas of the body as removal may remove hair.

• If pregnant or breast feeding consult a doctor before use.

• Keep out of reach of children.

Other Ingredients

Sesame oil, resin, zinc oxide, frankencense, myrrha, angelicae dahuricae radix, angelicae sinensis radix, paeoniae rubra radix, rhei rhizoma, scrophulariae radix, cinnamomum cortex, rehmanniae radix, momordicae semen, crinis carbonisatus, asa foetida, indigo carmine, tourmaline, tartrazine.

For Questions or Comments Call:

1 (800) 798-3977

Golden Sunshine Far Infrared COOL Herbal Patch pouch for 3 patches.

INGREDIENTS AND APPEARANCE

GOLDEN SUNSHINE FAR INFRARED COOL HERBAL 
topical analgesic patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67475-212
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	.005 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SESAME OIL (UNII: QX10HYY4QV)	.595 g  in 1 g
PINUS MASSONIANA RESIN (UNII: 64S07U83T7)	.2 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z)	.02 g  in 1 g
FRANKINCENSE (UNII: R9XLF1R1WM)	.014 g  in 1 g
MYRRH (UNII: JC71GJ1F3L)	.014 g  in 1 g
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)	.014 g  in 1 g
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)	.014 g  in 1 g
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)	.014 g  in 1 g
RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M)	.014 g  in 1 g
SCROPHULARIA NINGPOENSIS ROOT (UNII: HC0FB6P85R)	.014 g  in 1 g
CHINESE CINNAMON (UNII: WS4CQ062KM)	.014 g  in 1 g
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)	.014 g  in 1 g
MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)	.014 g  in 1 g
SCHORL TOURMALINE (UNII: 173O8XLY6T)	.01 g  in 1 g
HUMAN HAIR, CARBONIZED (UNII: UJ56P3G411)	.007 g  in 1 g
FERULA ASSA-FOETIDA WHOLE (UNII: CZ8MX5O89C)	.002 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	green	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67475-212-01	50 in 1 BOX	08/02/2004
1		3 in 1 POUCH
1		6 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 67475-212-02	10 in 1 BAG	08/02/2004
2		6 g in 1 PATCH; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
3	NDC: 67475-212-03	10 in 1 BAG	08/02/2004
3		3 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/02/2004

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(67475-212)