PROBLEND ALCOHOL HAND SANITIZER GEL- isopropyl alcohol gel

Problend Alcohol Hand Sanitizer Gel by

Drug Labeling and Warnings

Problend Alcohol Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Seatex, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpose

Isopropyl Alcohol 70% v/v..........Antiseptic

PURPOSE

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE

Uses

For hand sanitizing to decrease bacteria on the skin.

WARNINGS

Warnings For external use only.

Flammable. Keep away from heat or flame.

WHEN USING

When using this product Avoid contact with

eyes. In case of eye contact, flush eyes with water.

STOP USE

Stop use and ask a doctor if irritation or redness

develops and conditions persist for more than

72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get

medical help or contact a Poison Control Center

right away.

DOSAGE & ADMINISTRATION

Directions

Place enough product in your palm to

thoroughly cover hands

Rub hands together briskly until dry.

Children under 6 years of age shoud be

supervised when using this product.

INACTIVE INGREDIENT

Inactive Ingredients

Polyacrylic Acid, Water, Dye

PRINCIPAL DISPLAY PANEL

237 ml 76250-134-08

PRINCIPAL DISPLAY PANEL

473 mL 76250-134-16

PRINCIPAL DISPLAY PANEL

3.785 L 76250-134-01

PRINCIPAL DISPLAY PANEL

1249 L 76250.134-33

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

1.25 L Front 76250-134-25

PRINCIPAL DISPLAY PANEL

1.25 L Back 76250-134-25

INGREDIENTS AND APPEARANCE

PROBLEND ALCOHOL HAND SANITIZER GEL 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76250-134
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76250-134-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2020
2	NDC: 76250-134-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2020
3	NDC: 76250-134-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2020
4	NDC: 76250-134-33	1249000 mL in 1 CONTAINER; Type 0: Not a Combination Product	12/21/2020
5	NDC: 76250-134-55	201875 mL in 1 DRUM; Type 0: Not a Combination Product	06/28/2021
6	NDC: 76250-134-25	1250 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	08/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/21/2020

Labeler - Seatex, LLC (026647404)

Registrant - Seatex, LLC (026647404)

Establishment
Name	Address	ID/FEI	Business Operations
Seatex, LLC		026647404	manufacture(76250-134) , pack(76250-134) , label(76250-134)