ASEPSO ANTISEPTIC ORIGINAL- chloroxylenol soap

ASEPSO ANTISEPTIC ORIGINAL by

Drug Labeling and Warnings

ASEPSO ANTISEPTIC ORIGINAL by is a Otc medication manufactured, distributed, or labeled by CODAA Switzerland AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, water, glycerin, palm acid, fragrance, paraffinum liquidum, sodium chloride, palm kernel acid, iron oxides, tetrasodium EDTA, tetrasodium etidronate, FD&C Yellow No. 5, FD&C Blue No. 1.

Package Labeling:

INGREDIENTS AND APPEARANCE

ASEPSO ANTISEPTIC ORIGINAL 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49698-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
EDETATE SODIUM (UNII: MP1J8420LU)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49698-001-01	1 in 1 CARTON	02/03/2023
1		80 g in 1 BOX; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	02/03/2023

Labeler - CODAA Switzerland AG (483467697)