GERMSTARLUXE- ethyl alcohol solution

germstarLuxe by

Drug Labeling and Warnings

germstarLuxe by is a Otc medication manufactured, distributed, or labeled by 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

GERMSTARLUXE 
ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57915-007
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: 57915-007-01	8 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/01/2017
2	NDC: 57915-007-02	8 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/01/2017
3	NDC: 57915-007-03	8 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/01/2017
4	NDC: 57915-007-10	15 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/01/2019
5	NDC: 57915-007-11	15 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/01/2019
6	NDC: 57915-007-12	15 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/01/2019
7	NDC: 57915-007-13	15 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/01/2019
8	NDC: 57915-007-14	15 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/01/2019
9	NDC: 57915-007-15	118 g in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2019
10	NDC: 57915-007-16	118 g in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2019
11	NDC: 57915-007-17	118 g in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2019
12	NDC: 57915-007-18	118 g in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2019
13	NDC: 57915-007-19	118 g in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/01/2017

Labeler - Soaptronic, LLC (082741674)

Registrant - Soaptronic, LLC (082741674)

Establishment
Name	Address	ID/FEI	Business Operations
Soaptronic, LLC		082741674	manufacture(57915-007)