Anorectal by Amerisource Bergen / Inspec Solutions LLC Anorectal Cream [GNP]

Anorectal by

Drug Labeling and Warnings

Anorectal by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen, Inspec Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANORECTAL- lidocaine cream 
Amerisource Bergen

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Anorectal Cream [GNP]

Active ingredient                                 Purpose

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

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

ANORECTAL 
lidocaine cream

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	01/19/2021	12/09/2025

Labeler - Amerisource Bergen (007914906)

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

Revised: 12/2025

Document Id: 4585d89c-61a8-025e-e063-6394a90a75f3

34390-5

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

Version: 5

Effective Time: 20251209