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Mentholatum
methyl salicylate, dl-menthol · Mentholatum is an over-the-counter drug containing methyl salicylate, dl-menthol, made by Lydia Co., Ltd..
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Topical
- Manufacturers
- 1
■ Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily ■ children under 2 years of age: consult a doctor
Drug facts
- Generic name
- methyl salicylate, dl-menthol
- Active ingredients
- Menthol, Methyl Salicylate
- Dosage forms
- Lotion
- Label holder
- Lydia Co., Ltd.
- Label updated
- 07/06/2023
Active ingredients
Methyl Salicylate, DL-Menthol
Purpose
Temporary relief aches and pains of muscles and joints associated with:
- Arthritis
- Simple backache
- Sprains
- Strains
- Bruises
Uses
- Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily
- Children under 2 years of age: consult a doctor
Directions
Topocal use
Warnings
For external use only. Flammable
- Keep away from fire, flame, sparks and heated surfaces. Tight cap firmly. Stop use and ask a doctor if
- Condition worsens or symptoms persist for more than 7days or clear up and occur again within a few days When using this product
- Use only as direct
- Avoid contact with eyes
- Do not apply to wounds or damaged skin
- Do not bandage tightly If pregnant or breast-feeding, ask a health professional before use Keep out of reach of childre
Keep out of reach of children
Keep out of reach of children
Inactive ingredients
Mineral oil, lantrol, Sorbitan Monostearate, etc
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Lotion | 200 mg/g / 60 mg/g | topical | 1 |
Manufacturers and labels
1 FDA label
- Lydia Co., Ltd.Shown hereLabel 07/06/2023 · NDC 72988-0031Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing09/02/2026Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per...Church & Dwight Co., Inc. · CGMP Deviations; FDA inspection of the contract manufacturer noted...
- Class IIDrugOngoing07/29/2026Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%)...Rohto-Mentholatum (Vietnam) Co., Ltd. · 8 products · Lack of Assurance of Sterility
- Class IIDrugOngoing04/22/2026exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag...Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · 14 products · This recall is being initiated following FDA's recommendation...
- Class IIDrugOngoing01/21/2026Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d)...GOLD STAR DISTRIBUTION INC · CGMP Deviations: Insanitary conditions including rodent...
- Class IIDrugOngoing12/03/2025Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120...CA BOTANA International, Inc. · 2 products · CGMP Deviations
Mentholatum: common questions
- What is Mentholatum used for?
- ■ Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily ■ children under 2 years of age: consult a doctor
- Is Mentholatum a prescription drug?
- No. Mentholatum is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Mentholatum?
- Yes. Other FDA-listed products with the same active ingredients include Eagle Medicated, Heating Pain Relief, Eagle Brand Medicated Oil, Eagle Brand Medicated Roll On.
- Who makes Mentholatum?
- Lydia Co., Ltd. lists Mentholatum with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 07/06/2023 · Label text is shown as published by the manufacturer. Not medical advice