RECTOPROTECT- lidocaine cream

RectoProtect by

Drug Labeling and Warnings

RectoProtect by is a Otc medication manufactured, distributed, or labeled by Akron Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

temporarily relieves pain and itching due to anorectal disorders

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

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.

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

Questions or comments?

Call toll-free 1-877-255-6999

Manufactured for:

Akron Pharma Inc.

Fairfield, Nj 07004

www.akronpharma.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RECTOPROTECT 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-0050
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)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Product Characteristics
Color	white (clear gel)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-0050-1	1 in 1 CARTON	11/03/2023
1		5 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 71399-0050-2	1 in 1 CARTON	11/03/2023
2		30 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/03/2023

Labeler - Akron Pharma Inc. (067878881)