Mentholatum Lotion
FDA Label NDC 72988-0031

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lydia Co., Ltd. for the product Mentholatum (NDC 72988-0031). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, inactive ingredient, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

temporary relief aches and pains of muscles and joints associated with: • arthritis • simple backache • sprains • strains • bruises

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

■ 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

Warnings

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

Inactive Ingredient

mineral oil, lantrol, Sorbitan Monostearate, etc

Dosage & Administration

topocal use

Package Label.Principal Display Panel

Label (Label)

Label (Label)

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