SESDERMA LACTYFERRIN SANITIZER- benzalkonium chloride gel

SESDERMA LACTYFERRIN SANITIZER by

Drug Labeling and Warnings

SESDERMA LACTYFERRIN SANITIZER by is a Otc medication manufactured, distributed, or labeled by SESDERMA SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antiseptic

Uses

• to decrease bacteria on the skin that could cause disease.
• recommended for repeated use.

Warnings

For External Use Only.

Do not use

in the eyes. If this happens, rinse thoroughly with water.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control right away.

Allergy alert

• do not use this medication if you are allergic to chlorhexidine gluconate

Directions:

Apply a small amount over skin as often as needed. No-rinse.

Inactive ingredients:

water, lactoferrin, lecithin, propanediol, glycerin, menthol, lactoperoxidase, triethanolamine, bis-peg-18 methyl ether dimethyl silane, carbomer, ethylhexylglycerin, disodium edta, sodium chloride, fragrance, D&C 33, citric acid, sodium cholate, phenoxyethanol, polymethyl methacrylate, polysorbate 20, chlorhexidine digluconate.

Package Labeling:

INGREDIENTS AND APPEARANCE

SESDERMA LACTYFERRIN SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57943-0023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
MYELOPEROXIDASE (UNII: JQZ6YM58U5)
TROLAMINE (UNII: 9O3K93S3TK)
BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHOLATE (UNII: NU3Y4CCH8Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
LACTOFERRIN (SYNTHETIC HUMAN) (UNII: P0U6QZ2ZS7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57943-0023-1	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/22/2020

Labeler - SESDERMA SL (633606975)

Establishment
Name	Address	ID/FEI	Business Operations
SESDERMA SL		633606975	label(57943-0023) , manufacture(57943-0023)