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NDC 69420-6262-01 Lidocaine 4 Percent 4 g/100g Details

Lidocaine 4 Percent 4 g/100g

Lidocaine 4 Percent is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by SA3, LLC. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	69420-6262
Product ID	69420-6262_2ea89708-c9d8-4d24-af09-b3b6ddd53bd0
Associated GPIs
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 Percent
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 HYDROCHLORIDE
Labeler Name	SA3, LLC
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	2024-12-31

Package

Package Images

NDC 69420-6262-01 (69420626201)

Pricing Information	N/A
NDC Package Code	69420-6262-1
Billing NDC	69420626201
Package	120 g in 1 TUBE (69420-6262-1)
Marketing Start Date	2022-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 651710db-3c50-4bcf-b7cc-9ed24f663427 Details

SPL UNCLASSIFIED SECTION

LIDOCAINE - Lidocaine HCl 4% Cream

SA3, LLC

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 HCl 4% Topical Analgesic Cream

Drug Facts

Active ingredient

Lidocaine HCl 4% w/w

Purpose

Topical Analgesic

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

Avoid contact with the eyes
Do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
If allergic reaction occurs or if 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.

PRINCIPAL DISPLAY PANEL

Lidocaine HCl 4% cream

NDC 69420-6262-1

Topical Analgesic Cream

4.2 OZ (120 g)

SA3, LLC

INGREDIENTS AND APPEARANCE

LIDOCAINE 4 PERCENT

lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69420-6262
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	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)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)
LAURETH-7 (UNII: Z95S6G8201)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69420-6262-1	120 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/01/2022

Labeler - SA3, LLC (079627454)

Revised: 5/2022

Document Id: 2ea89708-c9d8-4d24-af09-b3b6ddd53bd0

Set id: 651710db-3c50-4bcf-b7cc-9ed24f663427

Version: 1

Effective Time: 20220517