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. 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

Wet hands and apply soap. Lather front and back, between your fingers, and under your nails. Scrub for at least 20 seconds, rinse then dry.

Inactive ingredients

Water, Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance, Citric Acid, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, 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

NEW

Softsoap®
brand

Antibacterial
Clean & Protect

ELIMINATES 99.9% OF BACTERIA
THAT POTENTIALLY CAUSE DISEASE*

ENRICHED WITH MOISTURIZERS

Cool Splash

Hand Soap
With Moisturizers

11.25 FL OZ
(332 mL)

0013086

INGREDIENTS AND APPEARANCE

SOFTSOAP ANTIBACTERIAL CLEAN AND PROTECT COOL SPLASH 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-096
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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
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: 35000-096-11	332 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	505G(a)(3)	11/23/2020

Labeler - COLGATE PALMOLIVE COMPANY (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive Company		079342773	ANALYSIS(35000-096) , MANUFACTURE(35000-096) , PACK(35000-096) , LABEL(35000-096)