Label: MENTHOLATUM- methyl salicylate, dl-menthol lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 6, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Methyl Salicylate, DL-Menthol

  • PURPOSE

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

  • 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

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    MENTHOLATUM 
    methyl salicylate, dl-menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72988-0031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE200 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL60 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72988-0031-175 g in 1 BOTTLE; Type 0: Not a Combination Product09/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/30/2022
    Labeler - Lydia Co., Ltd. (695735569)
    Registrant - Lydia Co., Ltd. (695735569)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lydia Co., Ltd.695735569manufacture(72988-0031)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!