GERMSTARANTIBACTERIALSOAP- triclosan solution
Soaptronic, LLC

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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germstarAntibacterialSoap

Active ingredient

Triclosan 0.6%

Purpose

Antiseptic Hand Soap

Uses

Hand wash to help reduce bacteria that potentially can cause disease.

Warnings

For external use only. Keep out of eyes. Consult doctor before use if you have deep wounds, animal bites, or serious burns. In case of eye contact immidiately flush eyes with water. If irritation persists, get medical attention. If swallowed, contact a Poison Control Center right away.

Keep out of reach of children.

Directions

Wet hands, apply soap, and lather for 30 sec and rinse hands thoroughly. Supervise children in the use of this product.

Inactive ingredients

Water, Propylene Glycol, Fragrance, FD&C green, Potassium Sorbate, Sodium Benzoate, Citric Acid, Lauryl Glucoside, Coco Betaine, Glycerine, Ammonium Lauryl Sulfate, Ethanol

Questions?

Call Germstar at 1-800.327.2606

label Germstar Antibacterial Soap

32oz

Label

GERMSTARANTIBACTERIALSOAP
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57915-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.06 g in 1000 g

Ingredient Name	Strength
Inactive Ingredients
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
COCO-BETAINE (UNII: 03DH2IZ3FY)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57915-006-01	946 g in 1 BAG; Type 0: Not a Combination Product	01/01/2009	07/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/01/2009	07/01/2016

Labeler - Soaptronic, LLC (082741674)

Registrant - Soaptronic, LLC (082741674)

Name	Address	ID/FEI	Business Operations
Establishment
Soaptronic, LLC		082741674	manufacture(57915-006)

Revised: 1/2017

Document Id: 471c713f-d988-66b9-e054-00144ff88e88

Set id: 2476df0c-1858-3cf8-e054-00144ff88e88

Version: 9

Effective Time: 20170127

Soaptronic, LLC