PROBLEND HAND SANITIZER GEL- ethanol gel 
Seatex, 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.

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Formula 27139 Problend

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

PB0027139 Hand Sanitizer 1 Gal

Problend Hand Sanitizer Gel Label-Front

PB0027139-Hand Sanitizer-1.25-L-FRONT-LABEL

Problend Hand Sanitizer Gel Label-Back

PB0027139-Hand-Sanitizer-1.25-L-BACK-LABEL

PROBLEND HAND SANITIZER GEL 
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76250-140
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 70 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76250-140-011249000 mL in 1 CONTAINER; Type 0: Not a Combination Product01/25/2023
2NDC:76250-140-02125000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product01/25/2023
3NDC:76250-140-0318900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/25/2023
Labeler - Seatex, LLC (026647404)
Registrant - Seatex, LLC (026647404)
Establishment
NameAddressID/FEIBusiness Operations
Seatex, LLC026647404label(76250-140) , manufacture(76250-140) , pack(76250-140)

Revised: 1/2023
Document Id: f32d1600-1e4f-642e-e053-2a95a90ad1bf
Set id: f319c0c7-1829-70ee-e053-2a95a90ac5ef
Version: 2
Effective Time: 20230126
 
Seatex, LLC