GERMSTARORIGINAL: Package Insert and Label Information

GERMSTARORIGINAL- isopropyl alcohol 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.

Active ingredient

Isopropyl alcohol 70% (W/W)

Purpose

Antiseptic

Uses

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

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.

Directions

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

Other information

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

Inactive ingredients

Water, Emollient Complex, fragrance.

Questions?

Call Germstar at 1-800.327.2606

GERMSTARORIGINAL isopropyl alcohol solution

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 700 g in 1000 g

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57915-001-01 946 g in 1 BAG None 2 NDC:57915-001-02 474 g in 1 BOTTLE, PUMP None 3 NDC:57915-001-03 236 g in 1 BOTTLE, SPRAY None 4 NDC:57915-001-04 59 g in 1 BOTTLE, SPRAY None 5 NDC:57915-001-05 8 g in 1 BOTTLE, SPRAY None 6 NDC:57915-001-06 3780 g in 1 BOTTLE None 7 NDC:57915-001-07 355 g in 1 BAG None

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	Operations
Soaptronic, LLC		082741674	manufacture (57915-001)

Revised: 08/2022 Soaptronic, LLC