Cetaphil Gentle Cleansing Antibacterial Bar

Drug Labeling and Warnings

Drug Details [pdf]

CETAPHIL GENTLE CLEANSING 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 Gentle Cleansing Antibacterial Bar

Active Ingredients

Triclosan 0.3%

Purpose

Antibacterial

Use

decrease bacteria on the skin

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 skin while bathing or washing.
• Rinse and repeat.
  

Inactive Ingredients:

Sodium Cocoyl Isethionate, Stearic Acid, Sodium Tallowate, Water, Sodium Stearate, Sodium Dodecylbenzene Sulfonate, Sodium Cocoate, PEG-20, Sodium Chloride, Masking Fragrance, Sodium Isethionate, Petrolatum, Sodium Isostearoyl Lactylate, Sucrose Cocoate, Titanium Dioxide, Pentasodium Pentetate, Tetrasodium Etidronate *May Also Contain Sodium Palm Kernelate

Questions?

1-866-735-4137

Cetaphil®

Gentle Cleansing Antibacterial Bar

FOR DRY, SENSITIVE SKIN

Non-comedogenic

Cetaphil®

Every Age. Every Stage. Every Day.

Gentle Cleansing

Antibacterial Bar

FOR DRY, SENSITIVE SKIN

Non-comedogenic

NET WT 4.5 oz (127 g)

GALDERMA

Cetaphil®

Gentle Cleansing Antibacterial Bar

This mild, non-soap cleansing bar is specially formulated to

provide both gentle skin cleansing and antibacterial benefits for dry, sensitive skin.

• Ideal for daily face and full body cleansing in the bath or shower
• Deodorizing agents leave skin feeling clean and fresh

Non-comedogenic/Dermatologist recommended

Marketed by:

Galderma Laboratories, LP.

Fort Worth, Texas 76177 USA

GALDERMA is a registered trademark

Made in USA

cetaphil.com

P51856-1

Cetaphil®

Every Age. Every Stage. Every Day.

Gentle Cleansing Antibacterial Bar

FOR DRY, SENSITIVE SKIN

Non-comedogenic

NET WT 4.5 oz (127 g) GALDERMA

CETAPHIL GENTLE CLEANSING ANTIBACTERIAL BAR  
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-3925
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Sodium Cocoyl Isethionate (UNII: 518XTE8493)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
SODIUM STEARATE (UNII: QU7E2XA9TG)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
SODIUM COCOATE (UNII: R1TQH25F4I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM ISETHIONATE (UNII: 3R36J71C17)
PETROLATUM (UNII: 4T6H12BN9U)
SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)
SUCROSE COCOATE (UNII: 3H18P0UK73)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-3925-04	127 g in 1 CARTON; Type 0: Not a Combination Product	01/02/2012	05/31/2019
2	NDC: 0299-3925-05	28 g in 1 CARTON; Type 0: Not a Combination Product	01/02/2012	08/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2012	05/31/2019

Labeler - Galderma Laboratories, L.P. (047350186)

Establishment
Name	Address	ID/FEI	Business Operations
Bradford Soap Works, Inc.		001201045	manufacture(0299-3925)

Revised: 9/2017

Document Id: e348d112-9e6f-4f68-93c3-f728ce595558

34390-5

Set id: 65861cc5-73de-4e60-8091-b7c832b92fc4

Version: 4

Effective Time: 20170907

 

Galderma Laboratories, L.P.