Your browser does not support JavaScript! MENTHOLATUM (CAMPHOR, MENTHOL) OINTMENT [THE MENTHOLATUM COMPANY]
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RxNorm Names

MENTHOLATUM (camphor, menthol) ointment
[The Mentholatum Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 Topical Analgesic Rub

Package/Label Principal Display Panel

Mentholatum Ointment

The Mentholatum Company

Orchard Park, NY, 14127

MENTHOLATUM 
camphor, menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/13/1976
Labeler - The Mentholatum Company (002105757)

Revised: 10/2010
Document Id: 1afca50f-d493-4ddd-8574-8b2ccc5bfbe1
Set id: 0c633ac9-7cc4-477d-8296-2a891ed4a867
Version: 2
Effective Time: 20101021
 
The Mentholatum Company

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