LIDOCAINE 4%- lidocaine cream

Lidocaine 4% by

Drug Labeling and Warnings

Lidocaine 4% 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, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine.

Package/Label Principal Display Panel

LIDOCAINE 4%
Topical Anesthetic Cream

120 grams

NDC: 50488-6262-1

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% 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50488-6262
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)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)
LAURETH-7 (UNII: Z95S6G8201)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
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: 50488-6262-1	120 g in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2016

Labeler - Alexso Inc. (963338061)