Asepso Lemon Antiseptic Soap

Asepso Lemon Antiseptic by

Drug Labeling and Warnings

Asepso Lemon Antiseptic by is a Otc medication manufactured, distributed, or labeled by CODAA SWITZERLAND AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ASEPSO LEMON 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.

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Asepso Lemon 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 77492, CI 77891, Tetrasodium Etidronate (HEDP) ,CI 19140.

Package Labeling:

ASEPSO LEMON ANTISEPTIC 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49698-005
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 PALM KERNELATE (UNII: 6H91L1NXTW)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PALMATE (UNII: S0A6004K3Z)
PALM ACID (UNII: B6G0Y5Z616)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PALM KERNEL ACID (UNII: 79P21R4317)
EDETATE SODIUM (UNII: MP1J8420LU)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49698-005-01	1 in 1 CARTON	08/11/2023	08/11/2023
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 not final	part333E	08/11/2023	08/11/2023

Labeler - CODAA SWITZERLAND AG (483467697)

Revised: 9/2023

Document Id: 04d3d6b2-5bf6-4e75-e063-6394a90a56ce

34390-5

Set id: 81c81307-f279-47e0-92bc-643ed55125d5

Version: 2

Effective Time: 20230908