ASEPSO SPORT ANTISEPTIC- chloroxylenol soap
CODAA SWITZERLAND AG

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.

----------

Asepso Sport Antiseptic Soap

Drug Facts

Active ingredient

Chloroxylenol 0.25%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin.

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

Wet hands and forearms.
Apply to hands and forearms. Scrub thoroughly for 60 seconds.
Rinse and repeat.

Other information

Do not use on fabrics. Store away from heat and humidity.

Inactive ingredients

Sodium Palmate, Sodium Palm Kernelate, Aqua, Fragrance, Glycerin, Palm Acid, Paraffinum Liquidum, Sodium Chloride, Palm Kernel Acid, Tetrasodium EDTA, CI 77891, Tetrasodium Etidronate (HEDP).

Package Labeling:

Label5

ASEPSO SPORT ANTISEPTIC
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49698-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	2.5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
SODIUM PALMATE (UNII: S0A6004K3Z)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PALM ACID (UNII: B6G0Y5Z616)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PALM KERNEL ACID (UNII: 79P21R4317)
EDETATE SODIUM (UNII: MP1J8420LU)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49698-006-01	1 in 1 CARTON	08/11/2023
1		80 g in 1 BOX; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/11/2023

Labeler - CODAA SWITZERLAND AG (483467697)

Revised: 9/2023

Document Id: 051a4e17-c668-ec4d-e063-6294a90aabe6

Set id: fee2fe19-857c-4d83-a3de-ac58ed404bce

Version: 3

Effective Time: 20230911

CODAA SWITZERLAND AG