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NDC 39328-0025-15 Lidocaine Anorectal 50 mg/g Details

Lidocaine Anorectal 50 mg/g

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

Product Information

NDC	39328-0025
Product ID	39328-025_a01912cb-9188-4002-8300-8daeaccf2539
Associated GPIs	89200025003720
GCN Sequence Number	040261
GCN Sequence Number Description	lidocaine CREAM (G) 5 % TOPICAL
HIC3	Q3H
HIC3 Description	HEMORRHOIDALS, LOCAL RECTAL ANESTHETICS
GCN	95404
HICL Sequence Number	010705
HICL Sequence Number Description	LIDOCAINE
Brand/Generic	Generic
Proprietary Name	Lidocaine Anorectal
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	RECTAL
Active Ingredient Strength	50
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	part346
Listing Certified Through	2024-12-31

Package

Package Images

NDC 39328-0025-15 (39328002515)

Pricing Information
NDC Package Code	39328-025-15
Billing NDC	39328002515
Package	1 TUBE in 1 CARTON (39328-025-15) / 15 g in 1 TUBE
Marketing Start Date	2018-11-01
NDC Exclude Flag	N
Price Per Unit	1.03413
Pricing Unit	GM
Effective Date	2023-09-20
NDC Description	LIDOCAINE ANORECTAL 5% CREAM
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 456d41fe-8449-4980-9291-d7a3b65a900d Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

Temporarily relieves pain and itching due to anorectal disorders

Warnings

When using this product

Avoid contact with eyes
Do not exceed recommended dosage unless directed by a doctor

Stop use and ask a doctor if

Rectal bleeding occurs
Condition worsens or does not improve within 7 days
Allergic reaction occurs
Redness, irritation, swelling, pain or other symptoms begin or increase
Symptoms clear up and return within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
Children under 12 years of age: Consult a doctor

Other information

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, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, and Vitamin E Acetate

Questions?

Call 800-936-3088

PRINCIPAL DISPLAY PANEL - 15 gram Tube Carton

NDC 39328-025-15

Lidocaine

5%

Anorectal Cream

PATRIN

PHARMA

NET WT. 15 grams

PRINCIPAL DISPLAY PANEL - 15 gram Tube Carton

INGREDIENTS AND APPEARANCE

LIDOCAINE ANORECTAL

lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:39328-025
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	50 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)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
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:39328-025-15	1 in 1 CARTON	11/01/2018
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:39328-025-30	1 in 1 CARTON	11/01/2018
2		30 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	part346	11/01/2018

Labeler - Patrin Pharma Inc. (806841677)

Revised: 4/2022

Document Id: a01912cb-9188-4002-8300-8daeaccf2539

Set id: 456d41fe-8449-4980-9291-d7a3b65a900d

Version: 1

Effective Time: 20220414