PROBLEND HAND SANITIZER GEL- ethanol gel

Problend Hand Sanitizer Gel by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active Ingredient Purpose

Ethanol 70% v/v....... Antiseptic

When using this product

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

Keep out of reach of children

If swallowed, get medical help or cantact a Poison Control Center right away.

Inactive Ingredients

Water, Glycerin, Polyacrylidc Acid, Fragrance, Dye.

Purpose Section

Antiseptic

Stop Use Section

Stop use and ask a doctor if irritation or redness develops and conditions persist for more than 72 hours.

Indications & Usage Section

Uses: For hand sanitizing to decrease bacteria on the skin.

Dosage and Administation Section

Directions

Place enough product in your palm to thoroughly cover hands. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

Warnings

For external use only. Flammable. Keep away from fire or flame.

Label

Problend Hand Sanitizer Gel Label-Front

Problend Hand Sanitizer Gel Label-Back

INGREDIENTS AND APPEARANCE

PROBLEND HAND SANITIZER GEL 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76250-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 70 mL

Inactive Ingredients
Ingredient Name	Strength
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76250-140-01	1249000 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/25/2023
2	NDC: 76250-140-02	125000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	01/25/2023
3	NDC: 76250-140-03	18900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/25/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/25/2023

Labeler - Seatex, LLC (026647404)

Registrant - Seatex, LLC (026647404)

Establishment
Name	Address	ID/FEI	Business Operations
Seatex, LLC		026647404	label(76250-140) , manufacture(76250-140) , pack(76250-140)