ZYLASTXP ANTISEPTIC FOAMING- benzethonium chloride soap

ZylastXP Antiseptic Foaming by

Drug Labeling and Warnings

ZylastXP Antiseptic Foaming by is a Otc medication manufactured, distributed, or labeled by Innovative Biodefense. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Benzethonium Chloride - 0.20%

Purpose

Antiseptic

Uses

• Handwash to decrease bacteria on the skin that potentially can cause disease.
• Recommended for repeated use.

Warnings

• For external use only.
• Avoid contact with eyes. In case of eye contact, rinse thoroughly with water.
• Discontinue use if irritation and redness develops. Consult a doctor if condition persists for more than 72 hours.  
• If swallowed, immediately call Poison Control Center or doctor.

Keep out of reach of children.

 If swallowed, immediately call Poison Control Center or doctor.

Directions

• Wet hands and forearms. Apply a palmful to hands and scrub hands and forearms thoroughly for 15 seconds or more. Rinse and repeat.

Other Inforamtion

• Store at 20-25°C (68-77°F) 

Inactive Ingredients

Water, Alcohol Denat., Lauramine Oxide, Cocamidopropyl Betaine, Cetrimonium Chloride, Butylene Glycol, Citric Acid, Zinc Gluconate, PPG-2 Hydroxyethyl Cocamide, Farnesol, Glycerin, Methylchloroisothiazolinone, Polyaminopropyl Biguanide, Fragrance, Polyquaternium-10.

Active Ingredients

Benzethonium Chloride - 0.20%

Purpose

Antiseptic

Uses

• Handwash to decrease bacteria on the skin that potentially can cause disease.
• Recommended for repeated use.

Warnings

• For external use only.
• Avoid contact with eyes. In case of eye contact, rinse thoroughly with water.
• Discontinue use if irritation and redness develops. Consult a doctor if condition persists for more than 72 hours.  
• If swallowed, immediately call Poison Control Center or doctor.

Directions

• Wet hands and forearms. Apply a palmful to hands and scrub hands and forearms thoroughly for 15 seconds or more. Rinse and repeat.

Other Information

• Store at 20-25°C (68-77°F)

Inactive ingredients

Water, Alcohol Denat., Lauramine Oxide, Cocamidopropyl Betaine, Cetrimonium Chloride, Butylene Glycol, Citric Acid, Zinc Gluconate, PPG-2 Hydroxyethyl Cocamide, Farnesol, Glycerin, Methylchloroisothiazolinone, Polyaminopropyl Biguanide, Fragrance, Polyquaternium-10.

Package/Label Principal Display Panel

NDC: 57362-467-01

Zylast XP

Extended Protection

Broad Spectrum

Antimicrobial

Antiseptic

Foaming Soap
8.25 oz

Package/Label Principal Display Panel

NDC: 57362-467-02

Zylast XP

Extended Protection

Broad Spectrum

Antimicrobial

Antiseptic

Foaming Soap

1000mL (33.8oz)

INGREDIENTS AND APPEARANCE

ZYLASTXP ANTISEPTIC FOAMING 
benzethonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57362-467
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)
FARNESOL (UNII: EB41QIU6JL)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
POLIHEXANIDE (UNII: 322U039GMF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57362-467-01	244 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2015
2	NDC: 57362-467-02	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/06/2015

Labeler - Innovative Biodefense (078363903)