ANORECTAL LIDOCAINE CREAM- lidocaine cream 
RUGBY LABORATORIES

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ANORECTAL Lidocaine Cream

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

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

Rugby-1339

ANORECTAL LIDOCAINE CREAM 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1339
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1339-281 in 1 CARTON09/04/2021
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34609/04/2021
Labeler - RUGBY LABORATORIES (079246066)
Registrant - Strive Pharmaceuticals Inc. (080028013)

Revised: 9/2021
Document Id: c98bfc2d-abb3-4bc3-b824-83e52f1bf0d8
Set id: bfeafe34-f502-4cbe-9197-4980100848da
Version: 1
Effective Time: 20210901
 
RUGBY LABORATORIES