SOFTSOAP ANTIBACTERIAL CLEAN AND PROTECT COOL SPLASH- benzalkonium chloride liquid

Softsoap Antibacterial Clean and Protect Cool Splash by

Drug Labeling and Warnings

Softsoap Antibacterial Clean and Protect Cool Splash by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company, VeePak, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

helps eliminate bacteria on hands

Warnings

For external use only.

When using this product, avoid contact with eyes.

In case of contact, flush with water.

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

Directions

wash hands and rinse

Inactive ingredients

Water, Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Cocamide MEA, Citric Acid, Sodium Benzoate, PEG-120 Methyl Glucose Dioleate, Fragrance, Sodium Chloride, Tetrasodium EDTA, Blue 1, Red 33.

Questions?

1-800-255-7552

SPL UNCLASSIFIED SECTION

DIST. BY: COLGATE-PALMOLIVE COMPANY,
NEW YORK, NY 10022 USA

PRINCIPAL DISPLAY PANEL - 332 mL Bottle Label

Softsoap®

ANTIBACTERIAL

clean & protect

ELIMINATES 99.9% OF BACTERIA
THAT CAN POTENTIALLY
CAUSE DISEASE*

ENRICHED WITH
MOISTURIZERS

cool splash
scent

ANTIBACTERIAL HAND SOAP

11.25 FL OZ (332 mL)

PS0064484

INGREDIENTS AND APPEARANCE

SOFTSOAP ANTIBACTERIAL CLEAN AND PROTECT COOL SPLASH 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-254
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.33 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE SODIUM (UNII: MP1J8420LU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-254-11	332 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/04/2022
2	NDC: 35000-254-91	1470 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/14/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	505G(a)(3)	10/04/2022

Labeler - COLGATE PALMOLIVE COMPANY (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive Company		079342773	ANALYSIS(35000-254) , MANUFACTURE(35000-254) , PACK(35000-254) , LABEL(35000-254)

Establishment
Name	Address	ID/FEI	Business Operations
VeePak, Inc		874763303	MANUFACTURE(35000-254)