SINGLE USE SURGICAL HAND SCRUB BRUSH- benzalkonium chloride sponge

Single Use Surgical Hand Scrub Brush by

Drug Labeling and Warnings

Single Use Surgical Hand Scrub Brush by is a Otc medication manufactured, distributed, or labeled by Hangzhou Hygen Health Biotechnology Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Patient Preoperative Skin Preparation/Surgical Hand Scrub

Uses

• For preparation of the skin prior to surgery.
• Helps reduce bacteria that potentially can cause skin infection.
• Significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care.

Warnings

For external use only

Do not use

in the eyes.

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Preoperative Skin Preparation: Wet the whole body of the patient. Scrub thoroughly for 1 minute. Rinse thoroughly. Repeat scrub and rinse thoroughly.
• Surgical Hand Scrub: Clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge. Wet hands and forearms. Scrub thoroughly for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces. Rinse and repeat scrub for 3 minutes. Rinse thoroughly.

Other information

• Avoid excessive heat (above 40°C / 104°F)
• Discard after single use.

Inactive ingredients

water, coco amido betaine, lauramine oxide, cellulose, PEG-6 caprylic/capric glycerides, glycerin, fragrance, sodium hydroxide

Package Labeling:

INGREDIENTS AND APPEARANCE

SINGLE USE SURGICAL HAND SCRUB BRUSH 
benzalkonium chloride sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73125-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
CAPRYLOCAPROYL POLYOXYLGLYCERIDES 6 (UNII: GO50W2HWO8)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73125-002-00	14 mL in 1 POUCH; Type 0: Not a Combination Product	12/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/20/2019

Labeler - Hangzhou Hygen Health Bio-technology Co. Ltd. (554488997)

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Hygen Health Bio-technology Co. Ltd.		554488997	manufacture(73125-002)