LIDOCAINE 4 PERCENT PLUS- lidocaine cream

Lidocaine 4 Percent PLUS by

Drug Labeling and Warnings

Lidocaine 4 Percent PLUS by is a Otc medication manufactured, distributed, or labeled by Alexso, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine HCl 4% w/w

Purpose

Topical anesthetic

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

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:

  ask a doctor

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

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Isostearyl Palmitate, Magnesium Sulfate, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine.

PRINCIPAL DISPLAY PANEL

NDC: 50488-6263-1

Lidocaine 4% PLUS Cream

120 grams

Manufactured for: Alexso, Inc.
2317 Cotner Avenue Los Angeles, CA 90064
Tel: 888.495.6078 Web: www.alexso.com

Label

INGREDIENTS AND APPEARANCE

LIDOCAINE 4 PERCENT PLUS 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50488-6263
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50488-6263-1	1 in 1 CARTON	10/01/2018
1		120 g in 1 TUBE; 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	10/01/2018

Labeler - Alexso, Inc. (963338061)