CETAPHIL MEN 3-IN-1 ACTIVE ANTIBACTERIAL BAR - triclosan soap 
Galderma Laboratories, L.P.

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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Cetaphil MEN 3-in-1 Active Antibacterial Bar

ACTIVE INGREDIENT:

TRICLOSAN 0.3%

PURPOSE:

ANTIBACTERIAL

USE:

DECREASE BACTERIA ON THE SKIN

Warnings:

For external use only

Keep out of reach of children except under adult supervision.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply to body and face in the shower or bath and work into a lather. Rinse.

INACTIVE INGREDIENTS:

SODIUM COCOYL ISETHIONATE, STEARIC ACID, SODIUM TALLOWATE, WATER, SODIUM STEARATE, SODIUM COCOATE, SODIUM DODECYLBENZENESULFONATE, SODIUM CHLORIDE, PEG-20, GLYCERIN, SODIUM ISETHIONATE, PETROLATUM, SUCROSE COCOATE, SODIUM ISOSTEAROYL LACTYLATE, MASKING FRAGRANCE, PENTASODIUM PENTETATE, TETRASODIUM ETIDRONATE, TITANIUM DIOXIDE, MAY ALSO CONTAIN PALM KERNELATE

                     Cetaphil Men 3-in-1 Active Bar Carton

Cetaphil®

MEN

3-in-1 Active Antibacterial Bar

Cetaphil®

MEN

3-in-1 Active Antibacterial Bar

Body + Face • For all skin types

Antibacterial + Deodorizing + Hydrating Power

For daily use on body and face

NET WT 4.5 OZ (127 g)

Not for Individual Sale

Cetaphil®

MEN • 3-in-1 Active Antibacterial Bar

Tackle surface bacteria and odor without drying out your skin. This full body cleansing bar deodorizes by getting rid of dirt, sweat, and odor-causing bacteria plus gives you triple-action moisturizing power without a residue. The result is healthy, smooth skin that's ready for a fresh start to your day or night.

Soap-free. Non-irritating. Unscented. Dermatologist developed and tested.

Distributed by: Galderma Laboratories, L.P.

Fort Worth, Texas 76177 USA

CETAPHIL is a registered trademark of GALDERMA.

cetaphil.com

P52918-0

ACTIVE INGREDIENT: TRICLOSAN 0.3%

PURPOSE: ANTIBACTERIAL

USE: DECREASE BACTERIA ON THE SKIN

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

Directions: Apply to body and face in the shower or bath and work into a lather. Rinse.

INACTIVE INGREDIENT: SODIUM COCOYL ISETHIONATE, STEARIC ACID, SODIUM TALLOWATE, WATER, SODIUM STEARATE, SODIUM COCOATE, SODIUM DODECYLBENZENESULFONATE, SODIUM CHLORIDE, PEG-20, GLYCERIN, SODIUM ISETHIONATE, PETROLATUM, SUCROSE COCOATE, SODIUM ISOSTEAROYL LACTYLATE, MASKING FRAGRANCE, PENTASODIUM PENTETATE, TETRASODIUM ETIDRONATE, TITANIUM DIOXIDE, MAY ALSO CONTAIN PALM KERNELATE

CETAPHIL MEN 3-IN-1 ACTIVE ANTIBACTERIAL BAR  
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)  
WATER (UNII: 059QF0KO0R)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
SODIUM COCOATE (UNII: R1TQH25F4I)  
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PEG-20 STEARATE (UNII: NBX892EA57)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM ISETHIONATE (UNII: 3R36J71C17)  
PETROLATUM (UNII: 4T6H12BN9U)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0299-4100-033 in 1 PACKAGE02/26/201611/30/2017
1127 g in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/01/201511/30/2017
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIBusiness Operations
Bradford Soap Works, Inc.001201045manufacture(0299-4100)

Revised: 9/2017
 
Galderma Laboratories, L.P.