ANTIBACTERIAL FOAM LAVENDER FRAGRANCE- triclosan soap
National Distribution & Contracting

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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Drug Facts

Active ingredient

Triclosan 0.3%

Purpose

Antiseptic Handwash

Use

Handwash to help reduce bacteria that potentially can cause disease

Warnings

For external use only

Ask a doctor before use if you have

Deep wounds, animal bites, or serious burns.

When using this product

Avoid contact with eyes. If this occurs, rinse thoroughly with water.

Stop use and ask a doctor if

irritation, itching or redness develops. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

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

Directions

Wet hands, apply foam, lather for 30 seconds and rinse hands thoroughly.

Inactive ingredients

Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Lauramide DEA, Cocamide DEA, Cocamidopropyl Betaine, Tetrasodium EDTA, DMDM Hydantoin, Diethanolamine, Fragrance, Methychloroisothiazolinone and Methylisothiazolinone, FD&C Red No. 4, FD&C Violet No. 2

Principal Display Panel

REF: P778208

NDC: 43128-208-03

Antibacterial Liquid Soap Foam

Lavender Fragrance

8 FL. OZ. (237 mL)

label

ANTIBACTERIAL FOAM LAVENDER FRAGRANCE
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43128-208
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
EDETATE SODIUM (UNII: MP1J8420LU)
DMDM HYDANTOIN (UNII: BYR0546TOW)
DIETHANOLAMINE (UNII: AZE05TDV2V)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C VIOLET NO. 2 (UNII: 350KA7O6HK)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43128-208-03	237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/01/2010	12/31/2016

Labeler - National Distribution & Contracting (009831413)

Revised: 1/2016

Document Id: 2a51e246-340e-09b1-e054-00144ff88e88

Set id: f6bd39ce-0ca5-4d52-9c97-2a2998464c3f

Version: 2

Effective Time: 20160127

National Distribution & Contracting