LIDOCAINE ANORECTAL- lidocaine cream

Lidocaine Anorectal by

Drug Labeling and Warnings

Lidocaine Anorectal by is a Otc medication manufactured, distributed, or labeled by Patrin Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

LIDOCAINE ANORECTAL 
lidocaine cream

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	11/01/2018

Labeler - Patrin Pharma Inc. (806841677)