SURGICAL SCRUB BRUSH/SPONGE WITH NAIL CLEANER 3.3% PCMX- chloroxylenol sponge

Surgical Scrub Brush/Sponge With Nail Cleaner 3.3% PCMX by

Drug Labeling and Warnings

Surgical Scrub Brush/Sponge With Nail Cleaner 3.3% PCMX by is a Otc medication manufactured, distributed, or labeled by Xinxiang Xinda Technology Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Chloroxylenol (pcmx), 3.3% w/w

Purpose

Surgical Hand Scrub

Use

Preoperative cleaning of healthcare personnel arms and hands.Significantly reduces the number of micro-organisms on the hands and forearms prior to surgery.

Warnings

For external use only.

Do not use

if redness or irritation occurs.

When using this product

avoid contact with eyes.

Stop use and ask a doctor if

severe adverse reactions occur.

Keep out of reach of children.

If swallowed or gets in eyes,get medical help or contact a Poison Control Center immediately.

Directions

●Wet hands, wrists and forearms to the elbows with water. Hands should be held higher than the elbows at all times

●Clean under nails with nail pick provided

●Use the brush side toclean the nails, cuticles and interdigital spaces between the fingersand the sponge side to scrub the hands and forearms. Wet sponge and squeeze to work up lather ·

●Scrub the nails, cuticles and interdigital spaces between the fingers, hands and forearms for 3 minutes in total . Scrub for an additional 2 minutes with using the sponge side only

●Rinse the hands, wrists and forearms with plenty of water

●Dry with a sterile towel from hands to elbows.Hold hands upwards.

Inactive ingredients

Ethano, Sodium dodecyl sulfate, Sodium Alcohol Ether Sulphate, Glycerol, Ethoxylated hydrogenated castor oil, Purified Water, Hydroxyethylcellulose

Other information

● Store at 20-25° (68-77°F).
● Avoid overheating 40°C (104 F)
● Discard after single use.

REF 2504-01A

INGREDIENTS AND APPEARANCE

SURGICAL SCRUB BRUSH/SPONGE WITH NAIL CLEANER 3.3% PCMX 
chloroxylenol sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84128-004
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
ALCOHOL (UNII: 3K9958V90M)
SODIUM LAURETH-5 SULFATE (UNII: 410Q7WN1BX)
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84128-004-01	30 in 1 BOX	02/27/2024
1		1 in 1 BAG
1		20 mL in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	02/27/2024

Labeler - Xinxiang Xinda Technology Co.,Ltd (546423962)

Establishment
Name	Address	ID/FEI	Business Operations
Xinxiang Xinda Technology Co.,Ltd		546423962	manufacture(84128-004)