Drug Facts

Active Ingredients
Methyl Salicylate 31.5%
Menthol 16%
Camphor 10%

Purpose
External Analgesic
External Analgesic
External Analgesic

Uses: For the temporary relief of minor aches and pains of muscles and joints associated withsimple backache, strains, bruises and sprains.

Warnings: FOR EXTERNAL USE ONLY

Do not use

Apply on wounds, irritated or damaged skin.
Otherwise than as directed

When using this product

Avoid contact with the eyes, mouth or mucous membranes.
Do not bandage tightly.

Stop use and ask a doctor if:

Condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.
Excessive irritation of the skin develops.
When using this product for arthritis: Pain persists for more than 10 days, redness is present or in conditions affecting children under 12 years of age

If pregnant or breast feeding, see the advise of a health professional before using this product.

Keep out of reach of children to avoid accidental poisoning. If swallowed, contact a Doctor or Poison Control Center immediately

Directions
Adults and children2 years of age and older: Apply to affected area not more than 3-4 times daily.
Children under 2 years of age: Do not use, consult a doctor

Inactive Ingredients: Eucalyptus oil, Olibanum, Myrhha resins, Corydalis rhizome and Drynaria fortunei extracts

Package Label

HERBALGY
camphor menthol methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66897-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	10 mL in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 mL in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	31.5 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
EUCALYPTUS OIL (UNII: 2R04ONI662)
FRANKINCENSE (UNII: R9XLF1R1WM)
MYRRH (UNII: JC71GJ1F3L)
CORYDALIS YANHUSUO TUBER (UNII: 0TUP42692Z)
DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66897-003-50	50 mL in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/15/2012

Labeler - Wicsun Trading (960476174)

Name	Address	ID/FEI	Business Operations
Establishment
Herbalgy Pharmaceutical Limited		667293554	manufacture