Package Insert and Label Information: Mentholatum Ironman Muscle Spray Extra Strength

By The Mentholatum Company | Last revised: 31 December 2009

MENTHOLATUM IRONMAN MUSCLE SPRAY EXTRA STRENGTH- camphor and menthol spray
The Mentholatum Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Camphor 4%

Menthol 8%

Purpose

Camphor — Topical Analgesic

Menthol — Topical Analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints due to

simple backache
arthritis
strains
bruises
sprains

Warnings

For external use only

Flammable: do not use near heat, flame, or while smoking

When using this product

use only as directed
avoid spraying in eyes or on mucous membranes. If contact occurs, rinse thoroughly with water.
do not apply over large areas of the body
do not apply to wounds or damaged skin
do not bandage tightly
do not use with a heating pad or apply external heat
do not puncture or incinerate. Contents under pressure.
do not store at temperatures above 120°F

Stop use and ask doctor if

skin redness or excessive irritation of the skin occurs
condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding

ask a healthcare professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over: spray a small amount to affected area not more than 3-4 times daily
children under 12 years: ask a doctor

Inactive ingredients

aesculus hippocastnum (horse chestnut) seed extract, alcohol (76% v/v), arnica montana flower extract, glycerin, methyl gluceth-20, purified water

Questions?

Toll free 1-877-636-2677 MON-FRI 9 AM TO 5 PM (EST)

Package/Label Principal Display Panel

(click image for full-size original)

Mentholatum Ironman Extra Strength Muscle Spray

Pain Relief for World Class Athletes

Topical Analgesic

Menthol and Camphor

MENTHOLATUM IRONMAN MUSCLE SPRAY EXTRA STRENGTH
menthol camphor spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10742-8152
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (CAMPHOR)	CAMPHOR	40 mg in 1 g
MENTHOL (MENTHOL)	MENTHOL	80 mg in 1 g

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:10742-8152-1	85 g in 1 CAN	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/01/2010

Labeler — The Mentholatum Company (002105757)

Revised: 12/2009 The Mentholatum Company