SAFEGUARD ANTIBACTERIAL FOAMING- benzalkonium chloride soap

Safeguard by

Drug Labeling and Warnings

Safeguard by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.12%

Purpose

Antiseptic Hand Cleanser

Uses

• For handwashing to decrease bacteria on the skin
• Recommended for repeated use

Warnings

• For external use only

When using this product

• Do not use in or near eyes

• Discontinue use if irritation and redness develop

Keep out of reach of children

In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

• Wet hands and forearms
• Apply enough product to adequately cover the entire surfaces of the hands and forearms
• Scrub thoroughly for at least 30 seconds (include the fingernails and the cuticles)
• Rinse

Other information

• Store in a cool dry place below 104° F

Inactive ingredients

Water, glycerine, cocoamidopropyl betaine, polyoxypropylene-polyoxyethylene block copolymer, benzyl alcohol, fragrance, phenoxyethanol, tetra sodium EDTA, dehydroacetic acid, FD&C Red #4, FD&C Yellow #5

Questions?

Contact Procter & Gamble Professional® Mon-Fri 9am - 5pm EST at 1-800-332-7787

PRINCIPAL DISPLAY PANEL - 1.2 L Bag Label

Procter & Gamble
Professional ®

Safeguard ®
AntiBacterial

Foaming Hand Soap
Benzalkonium Chloride Foaming Antibacterial Hand Soap

1.2L (1.26 QT) 40.5 FL OZ

INGREDIENTS AND APPEARANCE

SAFEGUARD  ANTIBACTERIAL FOAMING
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-601
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 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-601-40	1200 mL in 1 BAG; Type 0: Not a Combination Product	07/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/01/2010

Labeler - Procter & Gamble Manufacturing Company (004238200)

Establishment
Name	Address	ID/FEI	Business Operations
Best Sanitizers, Inc.		627278224	analysis(37000-601) , manufacture(37000-601) , pack(37000-601) , label(37000-601)