GOLDEN SUNSHINE HERBAL- topical analgesic spray

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]

PURPOSE

Topical Analgesic

Active Ingredients

Menthol 0.8% - Topical Analgesic, Wintergreen Oil 0.3% - Topical Analgesic

Indications

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

• simple backache
• arthritis
• strains
• bruises
• sprains

Directions

Hold can upright and spray until wet. Apply to clean and dry affected area 2 to 3 times daily as needed. Consult with a doctor for children under 6 years of age. Users with sensitive skin should test on a small area first.

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.
• Do not expose to heat or store at temperature above 120 degrees F.

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

• Keep out of reach of children.

Other Ingredients

Ethanol, lycopodii serrati herba, pseudoginseng radix, zingiber rhizoma, angelica dahuricae radix, paeoniae rubra radix, cinnamonomi cortex, jasmine oil.

For Questions or Comments Call:

1 (800) 798-3977

Golden Sunshine Herbal Spray sleeve for 120ml can.

INGREDIENTS AND APPEARANCE

GOLDEN SUNSHINE HERBAL 
topical analgesic spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67475-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.00781 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	.03 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)	.8197 g  in 1 g
HUPERZIA SERRATA (UNII: TLA53E5A4T)	.016 g  in 1 g
PANAX PSEUDOGINSENG ROOT (UNII: NMK0ZS613U)	.016 g  in 1 g
ZINGIBER MONTANUM ROOT (UNII: 3NG517NPD8)	.016 g  in 1 g
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)	.008 g  in 1 g
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)	.008 g  in 1 g
CHINESE CINNAMON (UNII: WS4CQ062KM)	.004 g  in 1 g
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)	.004 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67475-114-01	20 in 1 BOX	08/02/2004
1		1 in 1 BOX
1		105 g in 1 CAN; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 67475-114-02	4000 g in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	08/02/2004
3	NDC: 67475-114-03	7 g in 1 VIAL; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	08/02/2004

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(67475-114)