HERBALGY- camphor menthol methyl salicylate oil

Herbalgy by

Drug Labeling and Warnings

Herbalgy by is a Otc medication manufactured, distributed, or labeled by Herbalgy Pharmaceutical Limited . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose
External Analgesic
External Analgesic
External Analgesic

INDICATIONS & USAGE

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

WARNINGS

Warnings: FOR EXTERNAL USE ONLY

DO NOT USE

Do not use

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

WHEN USING

When using this product

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

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Package Label

INGREDIENTS AND APPEARANCE

HERBALGY  
camphor menthol methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66898-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66898-100-50	50 mL in 1 BOTTLE, GLASS

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

Labeler - Herbalgy Pharmaceutical Limited (667293554)

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