SOFTSOAP  ANTIBACTERIAL- triclosan liquid 
Colgate-Palmolive Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Softsoap®
brand
antibacterial
HAND SOAP

Drug Facts

Active ingredient

Triclosan 0.15%

Purpose

Antibacterial

Uses

helps eliminate germs 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, sodium C14-16 olefin sulfonate, lauramide DEA, sodium chloride, cocamidopropyl betaine, fragrance, DMDM hydantoin, citric acid, tetrasodium EDTA, polyquaternium -7, aloe barbadensis leaf juice, glycerin, hydrolyzed silk, FD&C red no. 40, FD&C yellow no. 5, D&C red no. 33

Questions or Comments?

1-800-432-8226

Dist. by: COLGATE-PALMOLIVE COMPANY Morristown, NJ 07962

PRINCIPAL DISPLAY PANEL - 3.78 Liter Bottle Label

PROFESSIONAL PRODUCTS
CP COLGATE-PALMOLIVE COMPANY

Softsoap®
brand

antibacterial
HAND SOAP

with light moisturizers
eliminates 99% of germs

Ideal for commercial use
in foodservice, office
supply, health care,
education and lodging

REFILL
1 Gallon (3.78 liters)

9868832

PRINCIPAL DISPLAY PANEL - 3.78 Liter Bottle Label
SOFTSOAP   ANTIBACTERIAL
triclosan liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-800
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan 1.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Sodium C14-16 olefin sulfonate (UNII: O9W3D3YF5U)  
Lauric Diethanolamide (UNII: I29I2VHG38)  
Sodium chloride (UNII: 451W47IQ8X)  
Cocamidopropyl betaine (UNII: 5OCF3O11KX)  
DMDM hydantoin (UNII: BYR0546TOW)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Edetate Sodium (UNII: MP1J8420LU)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Glycerin (UNII: PDC6A3C0OX)  
FD&C red no. 40 (UNII: WZB9127XOA)  
FD&C yellow no. 5 (UNII: I753WB2F1M)  
D&C red no. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
Color ORANGE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:35000-800-75 221 mL in 1 BOTTLE
2 NDC:35000-800-19 589 mL in 1 BOTTLE
3 NDC:35000-800-34 3780 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333E 09/01/2011
Labeler - Colgate-Palmolive Company (068693167)

Revised: 10/2012
Document Id: c4c85798-ecd7-47b4-b234-861cc7668188
Set id: a858a1a9-198c-41eb-b728-e3351d1be061
Version: 3
Effective Time: 20121002
 
Colgate-Palmolive Company