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NDC 50488-6262-01 Lidocaine 4% 4 g/100g Details

Lidocaine 4% 4 g/100g

Lidocaine 4% is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Alexso Inc.. The primary component is LIDOCAINE.

Product Information

NDC	50488-6262
Product ID	50488-6262_861bb5c9-6fc6-4d61-b96a-5c44006c8f26
Associated GPIs	90850060003720
GCN Sequence Number	075061
GCN Sequence Number Description	lidocaine HCl CREAM (G) 4 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	39982
HICL Sequence Number	001478
HICL Sequence Number Description	LIDOCAINE HCL
Brand/Generic	Generic
Proprietary Name	Lidocaine 4%
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	4
Active Ingredient Units	g/100g
Substance Name	LIDOCAINE
Labeler Name	Alexso Inc.
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 50488-6262-01 (50488626201)

Pricing Information	N/A
NDC Package Code	50488-6262-1
Billing NDC	50488626201
Package	120 g in 1 BOTTLE (50488-6262-1)
Marketing Start Date	2016-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 43705a1f-76ef-48d1-aa1a-c7b439266caa Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50488-6262-1	120 g in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2016

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

Labeler - Alexso Inc. (963338061)

Revised: 2/2019

Document Id: 861bb5c9-6fc6-4d61-b96a-5c44006c8f26

Set id: 43705a1f-76ef-48d1-aa1a-c7b439266caa

Version: 3

Effective Time: 20190212