GERMSTAR PREMIUM HAND SANITIZER- ethyl alcohol solution

Germstar Premium Hand Sanitizer by

Drug Labeling and Warnings

Germstar Premium Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Soaptronic LLC, Soaptronic, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Ethyl alcohol 63% (W/W)

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

Kills 99.99% of all disease causing germs on contact, and protects and restores moisture.

WARNINGS

Warnings

For external use only. Keep out of eyes. In case of eye contact immediately flush eyes with water. If irritation persists, get medical attention. If swallowed, contact physician. Flammable, keep away from heat or flames.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

Apply Germstar all over the surface of your hands and rub into skin until dry. Supervise children in the use of this product.

SPL UNCLASSIFIED SECTION

Other information

Germstar is non allergenic. Store at 20° to 25°C (68° to 77°F). May be harmful to some surfaces/materials.

INACTIVE INGREDIENT

Inactive ingredients

Water, Isopropanol, Emollient Complex, Fragrance

QUESTIONS

Questions?

Call Germstar at 1-800.327.2606

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GERMSTAR PREMIUM HAND SANITIZER 
ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57915-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	630 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57915-008-01	59 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/01/2017
2	NDC: 57915-008-02	59 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/01/2017
3	NDC: 57915-008-03	59 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/01/2017
4	NDC: 57915-008-04	59 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/01/2017
5	NDC: 57915-008-05	59 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/01/2017

Labeler - Soaptronic LLC (082741674)

Registrant - Soaptronic, LLC (082741674)

Establishment
Name	Address	ID/FEI	Business Operations
Soaptronic, LLC		082741674	manufacture(57915-008)