ANORECTAL LIDOCAINE CREAM- lidocaine cream

ANORECTAL Lidocaine Cream by

Drug Labeling and Warnings

ANORECTAL Lidocaine Cream by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES, Strive Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Warnings

For external use only

When using this product
avoid contact with eyes
do not exceed recommended 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
rectal bleeding occurs
condition worsens or does not improve within 7 days
allergic reaction occurs to ingredients in this product
symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
symptoms clear up and return within a few days

If pregnant or breast feeding, ask a health professional before use.

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). Avoid excessive heat and cold. Protect from sunlight.

Inactive ingredients

benzyl alcohol, carbomer, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, triethanolamine, vitamin E

Questions?

1-800-645-2158

SPL UNCLASSIFIED SECTION

Compare to the active ingredient in Recticare® Anorectal Cream††

For the temporary relief of anorectal itching & discomfort associated with hemorrhoids

Helps relieve pain, soreness & burning

Highest OTC lidocaine strength available

+ 10 FINGER COTS*

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF THE TUBE IS DAMAGED OR TAMPERED WITH.

Close cap tightly after each use.

††This product is not manufactured or distributed by Ferndale Healthcare®, Inc., a subsidiary of Ferndale Pharma Group, Inc., owner of the registered trademark RectiCare®.

Packaging

INGREDIENTS AND APPEARANCE

ANORECTAL LIDOCAINE CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1339
Route of Administration	TOPICAL

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, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
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 (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1339-28	1 in 1 CARTON	09/04/2021
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 final	part346	09/04/2021

Labeler - RUGBY LABORATORIES (079246066)

Registrant - Strive Pharmaceuticals Inc. (080028013)