MENTHOLATUM- camphor (synthetic) and menthol ointment 
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.

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Drug Facts

Active ingredients

Camphor 9%

Menthol, natural 1.3%

Purpose

Camphor - Topical Analgesic

Menthol, natural - Topical Analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints

Warnings

For external use only

When using this product

do not heat
do not microwave
do not add to hot water or any container where heating water. May cause splattering and result in burns.
do not get into eyes
do not apply to wounds or to damaged skin
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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
children under 2 years: ask a doctor

Inactive ingredients

fragrance, petrolatum, titanium dioxide

Questions?

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

www.mentholatum.com

Package/Label Principal Display Panel

Mentholatum Ointment
MENTHOLATUM 
camphor, menthol ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10742-0001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)90 mg  in 1 g
MENTHOL (MENTHOL) MENTHOL13 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-0001-11 in 1 CARTON
128 g in 1 JAR
2NDC:10742-0001-21 in 1 CARTON
285 g in 1 JAR
3NDC:10742-0001-31 in 1 CARTON
328 g in 1 TUBE
4NDC:10742-0001-41 in 1 CARTON
4106.3 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/13/1976
Labeler - The Mentholatum Company (002105757)

Revised: 6/2013
Document Id: ae76a4fe-5c6e-4e26-b452-20b9627c6182
Set id: 0c633ac9-7cc4-477d-8296-2a891ed4a867
Version: 4
Effective Time: 20130619
 
The Mentholatum Company