PAIN TERMINATOR ANALGESIC- topical analgesic patch

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.. 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
• menstrual pain

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. For menstrual pain, place on abdomen. 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, paeoniae veitchii radix, zinc oxide, drynariae rhizoma, angelicae sinensis radix, carthami flos, pyritum, draconis resina, frankencense, myrrha, terebinthina, ligustiei rhizoma, achyranthis radix, acanthopanacus cortex, acori rhizoma, atractylodis rhizoma, tourmaline, saussureae radix, gentianae macrophyllae radix, cnidii monnieri fructus, cinnamomum cortex, aconiti tuber, pinelliae tuber, dendrobii caulis, dioscoreae tokoro rhizoma, indigo carmine, tartrazine.

For Questions or Comments Call:

1 (800) 798-3977

PAIN Terminator pouch for 5 patches.

INGREDIENTS AND APPEARANCE

PAIN TERMINATOR ANALGESIC 
topical analgesic patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67475-312
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)	.471 g  in 1 g
PINUS MASSONIANA RESIN (UNII: 64S07U83T7)	.15 g  in 1 g
PAEONIA VEITCHII ROOT (UNII: VX6GD6M93V)	.04 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z)	.03 g  in 1 g
DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)	.02 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
FRANKINCENSE (UNII: R9XLF1R1WM)	.02 g  in 1 g
MYRRH (UNII: JC71GJ1F3L)	.02 g  in 1 g
LARIX DECIDUA RESIN (UNII: AD8LJ73GQF)	.02 g  in 1 g
LIGUSTICUM SINENSE ROOT (UNII: 32SLT970XO)	.016 g  in 1 g
ACHYRANTHES BIDENTATA ROOT (UNII: 5QIU26R6P1)	.01 g  in 1 g
ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB)	.01 g  in 1 g
ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)	.01 g  in 1 g
ATRACTYLODES JAPONICA ROOT (UNII: 58N5X5H9XU)	.01 g  in 1 g
SCHORL TOURMALINE (UNII: 173O8XLY6T)	.01 g  in 1 g
SAUSSUREA COSTUS ROOT (UNII: RUP970CGR9)	.006 g  in 1 g
GENTIANA MACROPHYLLA ROOT (UNII: 6559FC0U1B)	.006 g  in 1 g
CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)	.006 g  in 1 g
CHINESE CINNAMON (UNII: WS4CQ062KM)	.006 g  in 1 g
ACONITUM CARMICHAELII ROOT (UNII: XJ28061U1S)	.006 g  in 1 g
PINELLIA TERNATA ROOT (UNII: G9AET085M5)	.006 g  in 1 g
DENDROBIUM NOBILE STEM (UNII: CGO90PC910)	.006 g  in 1 g
TOKORO YAM (UNII: N57RVD5L6U)	.006 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	brown	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67475-312-01	50 in 1 BOX	05/18/2006
1		5 in 1 POUCH
1		3 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 67475-312-02	10 in 1 BAG	05/18/2006
2		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	05/18/2006

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(67475-312)