Safeguard Antibacterial Hand (Chloroxylenol) Liquid [Procter & Gamble Manufacturing Company] -

SAFEGUARD ANTIBACTERIAL HAND (CHLOROXYLENOL) LIQUID [PROCTER & GAMBLE MANUFACTURING COMPANY]
PDF | XML

NDC	69423-053-37, 69423-053-80
Set ID	a252f342-4019-4e0e-a588-d1b82df1065b
Category	HUMAN OTC DRUG LABEL
Packager	The Procter & Gamble Manufacturing Company
Generic Name
Product Class
Product Number
Application Number	PART333E

View All Sections

SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredient

Chloroxylenol 0.5%
Purpose

Antibacterial
Use
- For handwashing to decrease bacteria on skin. Recommended for repeated use.
Warnings

For external use only.

Do not use this product on infants under 6 months of age.

When using this product avoid contact with eyes. If this happens, rinse thoroughly with water.

Stop use if irritation occurs.

Keep out of reach of children, except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.
Directions

Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 20 seconds and rinse.
Inactive ingredients

Water, sodium lauryl sulfate, sodium laureth sulfate, cocamide MEA, phenoxyethanol, glycol distearate, cocamidopropyl betaine, sodium sulfate, citric acid, fragrance, guar hydroxypropyltrimonium chloride, DMDM hydantoin, tetrasodium EDTA, yellow 5, red 4
Questions?

1-800-332-7787 (professional sizes)

1-800-595-1375 (personal size)
SPL UNCLASSIFIED SECTION

Distr. by PROCTER & GAMBLE, CINCINNATI, OH 45202.
PRINCIPAL DISPLAY PANEL - 3.78 L Bottle Label
Liquid Ready-to-Use

Safeguard™ Antibacterial Hand Soap
- Helps remove bacteria from skin
Chloroxylenol Antibacterial Hand Soap

3.78 L/1 GALLON

INGREDIENTS AND APPEARANCE

SAFEGUARD ANTIBACTERIAL HAND
chloroxylenol liquid

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.5 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE SODIUM (UNII: MP1J8420LU)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM SULFATE (UNII: 0YPR65R21J)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69423-053-37	3780 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/01/2015
2	NDC:69423-053-80	800 mL in 1 POUCH; Type 0: Not a Combination Product	11/01/2015
3	NDC:69423-053-30	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/01/2015

Labeler - The Procter & Gamble Manufacturing Company (004238200)

View All Sections

Medic