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Lidocaine 4%

Dosage form: cream
Ingredients: LIDOCAINE 4g in 100g
Labeler: Alexso Inc
NDC Code: 50488-6262

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 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, 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

LIDOCAINE 4% 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50488-6262
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ARNICA MONTANA FLOWER 
INDIAN FRANKINCENSE 
CETOSTEARYL ALCOHOL 
CHONDROITIN SULFATE (BOVINE) 
DIMETHYL SULFONE 
ETHYLHEXYLGLYCERIN 
GLUCOSAMINE SULFATE 
GLYCERIN 
GLYCERYL 1-STEARATE 
C13-14 ISOPARAFFIN 
ISOSTEARYL PALMITATE 
LAURETH-7 
PEG-100 STEARATE 
PHENOXYETHANOL 
POLYACRYLAMIDE (10000 MW) 
PROPYLENE GLYCOL 
SODIUM POLYACRYLATE (2500000 MW) 
STEARIC ACID 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:50488-6262-1120 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2016
Labeler - Alexso Inc (070822737)

 
Alexso Inc

Medically reviewed on Dec 20, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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