ASSIST II ANORECTAL (HEMORRHOIDAL)- benzocaine liquid

Assist II by

Drug Labeling and Warnings

Assist II by is a Otc medication manufactured, distributed, or labeled by Texas Electrolysis Supply, Bio-Medical & Pharmaceutical Manufacturing Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Assist II Anorectal (Hemorrhoidal) Lotion

Active Ingredient

Benzocaine (20.0%)

Purpose

Topical Anesthetic

Indications

For the temporary relief of local discomfort associated with anorectal inflammation. For the temporary relief of pain, soreness, or burning.

Warnings

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. Certain persons can develop allergic reactions to ingredients in this product. If the symptom, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

KEEP OUT OF REACH OF CHILDREN

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 up to 3 times daily.

Children Under 12 Years Of Age: Consult a doctor.

Other Information

External Anesthetic

Inactive Ingredients

Ethanol, Benzyl Alcohol, Isopropyl Alcohol, Purified Water, Laureth 4, Tert-Butyl Alcohol, Brucine Sulfate.

Questions or Comments

Texas Electrolysis Supply

16627 Sealark Rd.

Houston, Texas 77062

Toll-Free: 1-800-626-6025

Internet: www.texaselectrolysisstore.com

PRINCIPAL DISPLAY PANEL

Assist II Anorectal (Hemorrhoidal) Lotion

INGREDIENTS AND APPEARANCE

ASSIST II  ANORECTAL (HEMORRHOIDAL)
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69550-324
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
BRUCINE SULFATE (UNII: KY7O12XPOQ)
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LAURETH-4 (UNII: 6HQ855798J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69550-324-18	236.588 mL in 1 CYLINDER; Type 0: Not a Combination Product	07/06/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	07/06/2015

Labeler - Texas Electrolysis Supply (093672462)

Establishment
Name	Address	ID/FEI	Business Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation		072186356	manufacture(69550-324)