LIDOCAINE HCL 4% MENTHOL 1% ointment

Lidocaine HCl 4% Menthol 1% by

Drug Labeling and Warnings

Lidocaine HCl 4% Menthol 1% by is a Otc medication manufactured, distributed, or labeled by WALGREENS CO.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine HCl 4%

Menthol 1%

INACTIVE INGREDIENT

benzyl alcohol, carbomer, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water triethanolamine, vitamin E

DOSAGE & ADMINISTRATION

Adults and children 12 years and older: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 to 4 applications in a 24-hour period.

BEFORE AND AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.

Children under 12 years: ask a doctor

INDICATIONS & USAGE

temporary relieves minor pain

WARNINGS

For external use only

Do not use on large areas of the body or on cut, irritated or swollen skin, on puncture wounds, for more than one week without consulting a doctor.

When using this product use only as directed. Read and follow all directions and warnings on this label, rare cases of serious burns have been reported with products of this type, do not bandage or apply local heat (such as heating pads) to the area of use or use with a medicated, avoid contact with eyes and mucous membranes, a transient burning sensation may occur upon application but generally disappears in several days.

Stop use and ask a doctor if condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days or clear up and occur again within a few days, you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children and pets.

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

KEEP OUT OF REACH OF CHILDREN

PURPOSE

Topical anesthetic

Topical analgesic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE HCL 4% MENTHOL 1% 
lidocaine hcl 4% menthol 1% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-4520
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER 940 (UNII: 4Q93RCW27E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-4520-72	76.5 g in 1 PACKAGE; Type 0: Not a Combination Product	01/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/04/2019

Labeler - WALGREENS CO. (008965063)