LIDOCAINE 4 PERCENT PLUS- lidocaine cream 
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.

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Lidocaine 4 Percent PLUS Cream

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

Lidocaine 4% PLUS cream NDC 50488-6263-1 Lidocaine 4% PLUS Topical Anesthetic Cream 120 grams Alexso, Inc

Label

LIDOCAINE 4 PERCENT PLUS 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50488-6263
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50488-6263-11 in 1 CARTON10/01/2018
1120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2018
Labeler - Alexso, Inc. (963338061)

Revised: 2/2019
Document Id: c462c364-268f-4f29-b846-4524d529d391
Set id: 75eca17e-af14-416e-bb24-5b94c1e68291
Version: 2
Effective Time: 20190212
 
Alexso, Inc.