MENTHOLATUM- dl-menthol, methyl salicylate lotion

MENTHOLATUM by

Drug Labeling and Warnings

MENTHOLATUM by is a Otc medication manufactured, distributed, or labeled by OASIS TRADING. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DL-Menthol, Methyl Salicylate

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 children

INACTIVE INGREDIENT

acetone, chloroxylenol, water

DOSAGE & ADMINISTRATION

For external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MENTHOLATUM 
dl-menthol, methyl salicylate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72689-0014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RACEMENTHOL (UNII: YS08XHA860) (RACEMENTHOL - UNII:YS08XHA860)	RACEMENTHOL	60 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACETONE (UNII: 1364PS73AF)
CHLOROXYLENOL (UNII: 0F32U78V2Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72689-0014-1	75 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/15/2018

Labeler - OASIS TRADING (689991468)

Registrant - OASIS TRADING (689991468)

Establishment
Name	Address	ID/FEI	Business Operations
OASIS TRADING		689991468	manufacture(72689-0014)