LIDOCAINE ANORECTAL CREAM- lidocaine 5% cream

Lidocaine anorectal cream by

Drug Labeling and Warnings

Lidocaine anorectal cream by is a Otc medication manufactured, distributed, or labeled by EveryMarket Inc, Inspec Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient                             Purpose

Lidocaine 5%                                    Local Anorectal(hemorrhoidal) Anesthetic

PURPOSE

INDICATIONS & USAGE

Uses For the temporary relief of local itching and discomfort associated with anorectal disorders. For temporary relief of pain,burning and soreness.

Directions

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
Apply to the affected area up to 6 times daily.
Children under 12 years of age: consult a doctor

Warnings (For external use only)

If condition worsens or does not improve within 7 days, consult a doctor.

Do not exceed the recommended daily dosage unless directed by a doctor.
In case of bleeding, consult a doctor promptly.
Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop and ask a doctor if -an allergic reaction occurs - symptom does not improve or if redness, irritation, swelling, pain or other symptom develop or increase.

Keep out of reach of children

. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.
(1-800-222-1222)

Inactive ingredients

Benzyl Alcohol, Carbomer, Cholesterol, DL ALPHA Tocopheryl Acetate.Hydrogenated Lecithin, lsopropyl Myristate, Polysorbate80, Propylene Glycol, Triethanolamine, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE ANORECTAL CREAM 
lidocaine 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85833-001
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
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER (UNII: 0A5MM307FC)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
CHOLESTEROL (UNII: 97C5T2UQ7J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85833-001-04	1 in 1 BOX, UNIT-DOSE	10/28/2025
1		113 g in 1 JAR; 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	10/28/2025

Labeler - EveryMarket Inc (079730558)

Registrant - Inspec Solutions (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions		081030372	manufacture(85833-001)