HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Solve Together, LLC, Organikisimo, S.A. de C:V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use(s)

For sanitizing to help reduce bacteria on the skin that potentially can cause disease.

Warnings

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

Do not use

• With children less than 2 months of age.
• On open skin wounds.

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Keep out of the reach of children unless under adult supervision. If swallowed, get medical help or contact a poison control center right away.

Directions

• Place enough product on hands to cover all surfaces.
• Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store in between 5°-30°C (41°-86°F)

Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

Water (Aqua), Carbomer, Glycerin, Triethanolamine, Tocopheryl Acetate (Vitamin E)

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
TRADEMARK BRAND LLC
1 Bridge Plaza N Ste 475
Fort Lee, NJ 07024

PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label

Safe Choice

TRADEMARK
BRAND

Zestfully Efficacious
HAND
SANITIZER

KILLS 99.9% OF GERMS*

Antibacterial

70% ALCOHOL

2 FL OZ (59 ML)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79882-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79882-001-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/19/2020
2	NDC: 79882-001-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/19/2020
3	NDC: 79882-001-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/19/2020
4	NDC: 79882-001-04	3700 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	11/19/2020

Labeler - Solve Together, LLC (117539166)

Establishment
Name	Address	ID/FEI	Business Operations
Organikisimo, S.A. de C:V		951579669	MANUFACTURE(79882-001)