ANTIMICROBIAL FOAMING HAND SANITIZER- benzalkonium chloride liquid

Antimicrobial Foaming Hand Sanitizer by

Drug Labeling and Warnings

Antimicrobial Foaming Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Saraya Healthcare, Best Sanitizers. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active Ingredient

Benzalkonium Chloride 0.12%

PURPOSE

Purpose

Antiseptic Hand Cleanser

INDICATIONS & USAGE

Uses​

• Hand wash to help reduce bacteria that potentially can cause diseases
• Helps to prevent cross-contamination
• Helps to prevent drying of the skin
• Recommended for repeated use

WARNINGS

Warnings

• For external use only

WHEN USING

When using this product

• Do not use in or near the eyes

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

• In case of accidental ingestion, seek medical attention or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

• Wet hands and forearms
• Apply appropriate amount to hands, wrists, and forearms
• Scrub thoroughly for at least 30 seconds (include the fingernails and the cuticles)
• Rinse with water

STORAGE AND HANDLING

Other information

• Store in a cool, dry place below 104°F

INACTIVE INGREDIENT

Inactive ingredients

Benzyl alcohol, cocoamidopropyl betaine, dehydroacetic acid, glycerine, phenoxyethanol, polyethylene-propylene glycol, tetra-sodium EDTA, water

QUESTIONS

Questions?

Call Saraya Healthcare USA Mon - Fri

9am - 4pm PST at 888.822.1801

SPL UNCLASSIFIED SECTION

Distributed by:

Saraya Healthcare USA

P.O. Box 1360

Penn Valley, CA 95946

866.822.1801

sarayahealthcareusa.com

SARAYA Healthcare USA

– 0.12% Benzalkonium Chloride (BZK) formula

– pH balanced

– Formulated with emollients to help keep skin soft

Antimicrobial Foaming Hand Soap

Net Contents: 1250mL (42 fl oz)

INGREDIENTS AND APPEARANCE

ANTIMICROBIAL FOAMING HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69674-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.12 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
EDETIC ACID (UNII: 9G34HU7RV0)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69674-210-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/14/2016
2	NDC: 69674-210-04	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/14/2016

Labeler - Saraya Healthcare (079729980)

Establishment
Name	Address	ID/FEI	Business Operations
Best Sanitizers		627278224	manufacture(69674-210)