PAIN TERMINATOR ANALGESIC- topical analgesic cream

PAIN Terminator Analgesic by

Drug Labeling and Warnings

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

Drug Details [pdf]

PURPOSE

Topical Analgesic

Active Ingredients

Menthol 2% - 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

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.

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

Jojoba oil, paeonia veitchii radix, angelicae sinensis radix, carthami flos, pyritum, draconis resina, myrrha, ligustici rhizoma, acanthopanacis cortex, achyranthis radix, atractylodis rhizoma, gentianae macrophyllae radix, pinelliae tuber, saussureae radix, cnidii monnieri fructus, cinnamonomi cortex, dioscoreae tokoro rhizoma, jasmine oil, tourmaline

For Questions or Comments Call:

1 (800) 798-3977

PAIN Terminator sleeve for 50g tube.

INGREDIENTS AND APPEARANCE

PAIN TERMINATOR ANALGESIC 
topical analgesic cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67475-313
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) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	.005 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
JOJOBA OIL (UNII: 724GKU717M)	.75 g  in 1 g
PAEONIA VEITCHII ROOT (UNII: VX6GD6M93V)	.04 g  in 1 g
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)	.02 g  in 1 g
CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0)	.02 g  in 1 g
PYRITIDIUM (UNII: 0PFV70949S)	.02 g  in 1 g
DAEMONOROPS DRACO RESIN (UNII: 787Z7N9UCU)	.02 g  in 1 g
MYRRH (UNII: JC71GJ1F3L)	.02 g  in 1 g
LIGUSTICUM SINENSE ROOT (UNII: 32SLT970XO)	.015 g  in 1 g
ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB)	.1 g  in 1 g
ACHYRANTHES BIDENTATA ROOT (UNII: 5QIU26R6P1)	.01 g  in 1 g
ATRACTYLODES JAPONICA ROOT (UNII: 58N5X5H9XU)	.01 g  in 1 g
GENTIANA MACROPHYLLA ROOT (UNII: 6559FC0U1B)	.006 g  in 1 g
PINELLIA TERNATA ROOT (UNII: G9AET085M5)	.006 g  in 1 g
SAUSSUREA COSTUS ROOT (UNII: RUP970CGR9)	.006 g  in 1 g
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)	.006 g  in 1 g
CHINESE CINNAMON (UNII: WS4CQ062KM)	.005 g  in 1 g
DIOSCOREA JAPONICA TUBER (UNII: I43FCF3356)	.005 g  in 1 g
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)	.003 g  in 1 g
SCHORL TOURMALINE (UNII: 173O8XLY6T)	.003 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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67475-313-01	500 g in 1 JAR; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	02/23/2009
2	NDC: 67475-313-02	12 in 1 BOX	02/23/2009
2		1 in 1 BOX
2		50 g in 1 TUBE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC: 67475-313-03	5 g in 1 TUBE; 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. <paragraph/></text> (098930857)

Establishment
Name	Address	ID/FEI	Business Operations
Golden Sunshine International, Inc. <paragraph/></text>		098930857	label(67475-313)