LIDOCAINE AND MENTHOL - Lidocaine 4% and Menthol 1% Gel
Alexso, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Lidocaine 4% and Menthol 1% Gel

Drug Facts

Active ingredient

Purpose

Lidocaine 4% ………………………..Topical anesthetic
Menthol 1% …………………………Topical analgesic

Uses

Temporarily relieves pain and itching due to:

minor cuts
sunburn
minor scrapes
minor burns
insect bites
minor skin irritations

Warnings

For external use only.

When using this product

do not use in or near the eyes
do not use in large quantities, particularly over raw surfaces or blistered areas
do not apply to wounds or damaged skin
do not bandage

Stop use and ask a doctor if

allergic reaction occurs
condition worsens or does not improve within 7 days
symptoms clear up and return within a few days
redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of reach of children.

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

Directions

adults and children 2 years and older	apply externally to the affected area up to 3 to 4 times a day
children under 2 years	do not use except under the advice and supervision of a physician

Other information

May be applied under occlusive dressing.
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Ethylhexylglycerin, Glucosamine Sulfate, Ilex Paraguariensis (Yerba Mate’) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Triethanolamine, Zemea (Corn) Propanediol

Lidocaine 4% and Menthol 1% Gel

NDC 50488-6641-1

120 grams

Manufactured for:
Alexso, Inc.
Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

NDC 50488-6641-1
Lidocaine 4% + Menthol 1%
120 grams

PRINCIPAL DISPLAY PANEL
NDC 50488-6641-1
Lidocaine 4% + Menthol 1%
120 grams

LIDOCAINE AND MENTHOL
lidocaine, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50488-6641
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4.8 g in 120 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.2 g in 120 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)
CORN (UNII: 0N8672707O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50488-6641-1	120 g in 1 TUBE; Type 0: Not a Combination Product	02/17/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	02/17/2021

Labeler - Alexso, Inc (963338061)

Lidocaine and Menthol Gel