MENTHOLATUM- methyl salicylate, dl-menthol lotion

Mentholatum by

Drug Labeling and Warnings

Mentholatum by is a Otc medication manufactured, distributed, or labeled by Lydia Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MENTHOLATUM 
methyl salicylate, dl-menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72988-0031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	200 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72988-0031-1	75 g in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/30/2022

Labeler - Lydia Co., Ltd. (695735569)

Registrant - Lydia Co., Ltd. (695735569)

Establishment
Name	Address	ID/FEI	Business Operations
Lydia Co., Ltd.		695735569	manufacture(72988-0031)