MENTHOLATUM PAIN RELIEVING- menthol, methyl salicylate lotion

Mentholatum Pain Relieving by

Drug Labeling and Warnings

Mentholatum Pain Relieving by is a Otc medication manufactured, distributed, or labeled by The Mentholatum Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Menthol 6%

Methyl salicylate 20%

Purpose

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints due to

• arthritis
• simple backache
• strains
• sprains

Warnings

For external use only

When using this product

• use only as directed
• do not get into eyes or on mucous membranes
• do not apply to wounds or to damaged skin
• do not bandage tightly
• do not use with a heating pad, other heat sources, or right after a shower/bath
• do not use in combination with other external analgesic products

Stop use and ask a doctor if

• condition worsens
• excessive irritation, burning or discomfort of the skin develops
• symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

ask a healthcare professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
• children under 12 years: ask a doctor

Inactive ingredients

carbomer, lanolin oil, polysorbate 60, purified water, sorbitan monosterate, trolamine

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

MENTHOLATUM PAIN RELIEVING 
menthol, methyl salicylate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-8169
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	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
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
LANOLIN OIL (UNII: OVV5IIJ58F)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-8169-1	1 in 1 CARTON	11/01/2018
1		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 10742-8169-2	1 in 1 CARTON	11/01/2018
2		75 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/01/2018

Labeler - The Mentholatum Company (002105757)