MENTHOLATUM- methyl salicylate, dl-menthol lotion 
Lydia Co., Ltd.

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.

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Methyl Salicylate, DL-Menthol

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

Keep out of reach of children

■ 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 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

mineral oil, lantrol, Sorbitan Monostearate, etc

topocal use

label

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)

Revised: 7/2023
Document Id: ffcab802-a76f-e425-e053-6294a90acf76
Set id: e9db590f-b19a-3fe8-e053-2995a90a4e74
Version: 3
Effective Time: 20230706
 
Lydia Co., Ltd.