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Mentholatum original - Medication Information

Product NDC Code 10742-0002
Drug Name

Mentholatum original

Type Brand
Active Ingredients
Camphor (natural) 90 mg/g
Menthol, unspecified form 13 mg/g
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 1042663,
1042667
Application Number part348
Labeler Name The Mentholatum Company
Packages
Package NDC Code Description
10742-0002-1 1 jar in 1 carton (10742-0002-1) / 28 g in 1 jar
10742-0002-2 1 jar in 1 carton (10742-0002-2) / 85 g in 1 jar
10742-0002-3 1 jar in 1 carton (10742-0002-3) / 34 g in 1 jar
10742-0002-4 1 jar in 1 carton (10742-0002-4) / 102.1 g in 1 jar
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Camphor 9% Menthol 1.3%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients fragrance, petrolatum, titanium dioxide

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses temporarily relieves minor aches and pains of muscles and joints

Purpose

Information about the drug product’s indications for use.
Purpose Camphor - Topical Analgesic Menthol - Topical Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
Mentholatum Original camphor, menthol PETROLATUM TITANIUM DIOXIDE CAMPHOR (NATURAL) CAMPHOR (NATURAL) MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package/Label Principal Display Panel Mentholatum Original Ointment

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-877-636-2677 MON-FRI 9AM to 5PM (EST)

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product do not get into eyes do not apply to wounds or to damaged skin do not bandage tightly do not heat, microwave, or add to hot water as this may cause splattering and result in burns

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only When using this product do not get into eyes do not apply to wounds or to damaged skin do not bandage tightly do not heat, microwave, or add to hot water as this may cause splattering and result in burns 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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API