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NDC 46122-0652-03 Anorectal 5 g/100g Details

Anorectal 5 g/100g

Anorectal is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Amerisource Bergen. The primary component is LIDOCAINE.

Product Information

NDC	46122-0652
Product ID	46122-652_d5cb27f7-cd53-3dfa-e053-2995a90a35c9
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	Anorectal
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	5
Active Ingredient Units	g/100g
Substance Name	LIDOCAINE
Labeler Name	Amerisource Bergen
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	2023-12-31

Package

Package Images

NDC 46122-0652-03 (46122065203)

Pricing Information
NDC Package Code	46122-652-03
Billing NDC	46122065203
Package	1 TUBE in 1 CARTON (46122-652-03) / 28 g in 1 TUBE
Marketing Start Date	2021-01-19
NDC Exclude Flag	N
Price Per Unit	0.32693
Pricing Unit	GM
Effective Date	2022-03-23
NDC Description	GNP LIDOCAINE ANORECTAL 5% CRM
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2022-11-23

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 e66da6eb-7ee8-416d-a20f-45e5c42d47d6 Details

Active ingredient Purpose

Lidocaine 5%........................................Local Anesthetic

SPL UNCLASSIFIED SECTION

Uses

For temporary relief of local and anorectal discomfort associated with anorectal discomfort or inflammation.

Warnings For external use only.

When using this product • do not get into eyes. • do not exceed the recommended daily dosage unless directed by a doctor • do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if • condition worsens or does not improve within 7 days. • in case of bleeding, consult a doctor promptly • Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get help or contact a Poison Control Center right away.

Directions

Cleanse affected area and gently dry. Apply externally to the affected area up to 6 times daily, especially at night, in the morning or after each bowel movement • Children under 12 years of age: consult a doctor.

Other Information

Store at 25° C (77°F); excursions permitted to 15-30° C (59-86° F).

Inactive ingredients

Benzyl Alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water,

Trolamine, Vitamin E Acetate.

Questions?

888-793-8450

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANORECTAL

lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-652
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER 940 (UNII: 4Q93RCW27E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:46122-652-03	1 in 1 CARTON	01/19/2021
1		28 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	01/19/2021

Labeler - Amerisource Bergen (007914906)

Name	Address	ID/FEI	Business Operations
Establishment
Inspec Solutions LLC		081030372	manufacture(46122-652)

Revised: 1/2022

Document Id: d5cb27f7-cd53-3dfa-e053-2995a90a35c9

Set id: e66da6eb-7ee8-416d-a20f-45e5c42d47d6

Version: 3

Effective Time: 20220117