SURGICAL SCRUB BRUSH/SPONGE WITH NAIL CLEANER 3.3% PCMX- chloroxylenol sponge 
Xinxiang Xinda Technology Co.,Ltd

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84128-004

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

20ML

SURGICAL SCRUB BRUSH/SPONGE WITH NAIL CLEANER 3.3% PCMX 
chloroxylenol sponge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84128-004
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84128-004-0130 in 1 BOX02/27/2024
11 in 1 BAG
120 mL in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00302/27/2024
Labeler - Xinxiang Xinda Technology Co.,Ltd (546423962)
Establishment
NameAddressID/FEIBusiness Operations
Xinxiang Xinda Technology Co.,Ltd546423962manufacture(84128-004)

Revised: 2/2024
Document Id: 125b3fb8-232a-505a-e063-6294a90abde0
Set id: 125b3c3b-0a3a-9fd3-e063-6394a90a135a
Version: 1
Effective Time: 20240227
 
Xinxiang Xinda Technology Co.,Ltd