Germasidol: Package Insert and Label Information

GERMASIDOL- triclosan soap
The Dodge Company Inc.

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.

INDICATIONS & USAGE SECTION

Antiseptic handwash for handwashing to decrease baceria on the skin

OTC — PURPOSE SECTION

Antiseptic handwash

OTC — KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Moisten surface to be cleaned, apply soap, rub to create lather, and rinse. Repeat as needed.

WARNINGS SECTION

1) For external use only.

2) Do not use in the eyes.

3) Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor

OTC — ACTIVE INGREDIENT SECTION

Triclosan

INACTIVE INGREDIENT SECTION

Carboxymethylcellulose Sodium

Carboxymethylcellulose Sodium xxxxxxxxx

Cocamidopropyl Betaine

D&C Yellow #8

Propylene Glycol

Trisodium EDTA

Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dodge Germasidol 8.5oz.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dodge Germasidol 16oz.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dodge Germasidol 24oz.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

odge Germasidol Gal.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dodge Germasidol 5 Gal.jpg

GERMASIDOL triclosan soap

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:25113-333 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (TRICLOSAN) TRICLOSAN 0.0057 g in 1 g

Inactive Ingredients Ingredient Name Strength WATER EDETATE TRISODIUM D&C YELLOW NO. 8 PROPYLENE GLYCOL COCAMIDOPROPYL BETAINE CARBOXYMETHYLCELLULOSE SODIUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:25113-333-85 256 g in 1 BOTTLE None 2 NDC:25113-333-16 483 g in 1 BOTTLE None 3 NDC:25113-333-24 769 g in 1 BOTTLE None 4 NDC:25113-333-01 3860 g in 1 JUG None 5 NDC:25113-333-05 19303 g in 1 JUG None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/29/2014

Labeler — The Dodge Company Inc. (001045517)

Establishment
Name	Address	ID/FEI	Operations
Bayscience Formulators LLC		162930544	manufacture (25113-333)

Revised: 04/2014 The Dodge Company Inc.