GERMSTARORIGINAL- isopropyl alcohol solution

GERMSTARORIGINAL by

Drug Labeling and Warnings

GERMSTARORIGINAL 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

Isopropyl alcohol 70% (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. Germstar Wipes are safe for most surfaces, however can be harmful to some. Test wipe on a non-conspicuous area if unsure.

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, Emollient Complex, fragrance.

QUESTIONS

Questions?

Call Germstar at 1-800.327.2606

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GERMSTARORIGINAL 
isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57915-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	700 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: 57915-001-01	946 g in 1 BAG; Type 0: Not a Combination Product	01/01/2000
2	NDC: 57915-001-02	474 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2000
3	NDC: 57915-001-03	236 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2000
4	NDC: 57915-001-04	59 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2000
5	NDC: 57915-001-05	8 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2000

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2000

Labeler - Soaptronic, LLC (082741674)

Registrant - Soaptronic, LLC (082741674)

Establishment
Name	Address	ID/FEI	Business Operations
Soaptronic, LLC		082741674	manufacture(57915-001)