LA FLECHA JAPONESA- methyl salicylate oil

La Flecha Japonesa by

Drug Labeling and Warnings

La Flecha Japonesa by is a Otc medication manufactured, distributed, or labeled by Menper Distributors, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts 

Active Ingredients                                                                                     Purpose         

Methyl Salicate 10.5%..............................................................External Analgesic

Purpose 

External Analgesic 

Uses 

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

• simple backache
• arthrits
• strains
• sprains

WARNINGS

For external use only. Do not use otherwise than as directed.

Do not use 

• with a bandage
• on wounds or damage skin 
• with a heating pad
• on a child under 12 years of age
• over extensive areas of the body
• on irritated skin 

Ask a doctor before use if you have 

redness over the affected area

When using this product

• avoid contact with eyes or mucuos membranes 
• do not bandage

Stop use and ask a doctor if 

• condition worsen or symptoms persists for more than 7 days 
• symptoms clear up and occur again within a few days 
• excessive skin irritation occurs 

if pregnant or breast-feeding 

ask a health professional before use

Keep out of the reach of children to avoid accidental poisoning.

If swallowed, induce vomiting and call a physician or contact a Poison Control  Center right away.

Directions 

use only as directed

• adults and children 12 years of age and older: apply to affected area no more than 3 to 4 times daily
• children under 12 years of age: ask a doctor

Other information 

• store at 15° to 25° C (59° to 77° F)

Inactive Ingredients

cajeput oil, clove oil, essential oil of peppermint, eucalyptus oil, juniper, menthol, white mineral oil.

Questions?

1-800-560-5223 M-F 9 AM to 4 PM Eastern.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA FLECHA JAPONESA 
methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-047
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	105 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAJUPUT OIL (UNII: J3TO6BUQ37)
CLOVE OIL (UNII: 578389D6D0)
PEPPERMINT OIL (UNII: AV092KU4JH)
EUCALYPTUS OIL (UNII: 2R04ONI662)
JUNIPER BERRY OIL (UNII: SZH16H44UY)
MENTHOL (UNII: L7T10EIP3A)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-047-01	1 in 1 CARTON	02/21/2012
1		15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	02/21/2012

Labeler - Menper Distributors, Inc. (101947166)