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NDC 39328-0024-55 Lidocaine 40 mg/g Details

Lidocaine 40 mg/g

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

Product Information

NDC	39328-0024
Product ID	39328-024_1c506667-9c89-4467-ac09-d1da6b67fd48
Associated GPIs	90850060003720 90859902896420
GCN Sequence Number	040262
GCN Sequence Number Description	lidocaine CREAM (G) 4 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	95405
HICL Sequence Number	010705
HICL Sequence Number Description	LIDOCAINE
Brand/Generic	Generic
Proprietary Name	Lidocaine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	40
Active Ingredient Units	mg/g
Substance Name	LIDOCAINE
Labeler Name	Patrin Pharma Inc.
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 39328-0024-55 (39328002455)

Pricing Information	N/A
NDC Package Code	39328-024-55
Billing NDC	39328002455
Package	5 TUBE in 1 CARTON (39328-024-55) / 5 g in 1 TUBE
Marketing Start Date	2018-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 91eedf9d-53b8-49d5-af59-25019606a0b2 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Lidocaine 4% w/w

Purpose

Topical anesthetic

Uses

temporarily relieves pain and itching due to

minor cuts
minor scrapes
minor burns
sunburn
minor skin irritation
insect bites

Directions

Adult and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day.
Children under 2 years of age: Consult a doctor.

Warnings

For external use only.

Do not use

in or near the eyes
in large quantities, particularly over raw 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.

Other Information

May be applied under occlusive dressing.
Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Inactive ingredients

Benzyl Alcohol, Carbopol 940, Hydrogenated Lecithin, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E Acetate.

Questions?

Call 800-936-3088

PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton

NDC 39328 - 024 - 30

Lidocaine 4%

Topical Anesthetic Cream

FOR EXTERNAL USE ONLY

PATRIN

PHARMA

Net Wt. 30 grams

PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton

INGREDIENTS AND APPEARANCE

LIDOCAINE

lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:39328-024
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Benzyl Alcohol (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Trolamine (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:39328-024-55	5 in 1 CARTON	11/01/2018
1		5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:39328-024-15	1 in 1 CARTON	11/01/2018
2		15 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:39328-024-30	1 in 1 CARTON	11/01/2018
3		30 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:39328-024-56	5 in 1 CARTON	11/01/2018
4		5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part348	11/01/2018

Labeler - Patrin Pharma Inc. (806841677)

Revised: 4/2022

Document Id: 1c506667-9c89-4467-ac09-d1da6b67fd48

Set id: 91eedf9d-53b8-49d5-af59-25019606a0b2

Version: 2

Effective Time: 20220408