HAND SANITIZER GEL- alcohol gel gel

Hand Sanitizer Gel by

Drug Labeling and Warnings

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

Drug Details [pdf]

DESCRIPTION

Hand Sanitizer Gel

Moisturizing with Aloe

Effective at eliminating more than 99.9% of many common harmful germs & bacteria in as little as 15 seconds.

ACTIVE INGREDIENT

Active ingredient

Isopropyl Alcohol 70% v/v

PURPOSE

Purpose

Antimicrobial

INDICATIONS & USAGE

Uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Recommended for repeated use.

WARNINGS

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

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 your hands Rub hands together briskly until dry.

No rinsing required.

No towels needed .

INACTIVE INGREDIENT

Inactive ingredients

Water (Aqua), Aloe Vera, Propylene Glycol, Carboxethyl Acrylate Crosspolymer

OTHER SAFETY INFORMATION

Other information

Do not store above 110°F (43°C)  May discolor certain fabrics or surfaces

SPL UNCLASSIFIED SECTION

Manufactured By: AgroChem, Inc 26 Freedom Way Saratoga Springs, NY 12866

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER GEL 
alcohol gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17307-1110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17307-1110-1	470 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/24/2020
2	NDC: 17307-1110-2	940 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/24/2020
3	NDC: 17307-1110-3	3780 mL in 1 JUG; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/24/2020

Labeler - AgroChem Inc (805427700)

Registrant - AgroChem Inc (805427700)

Establishment
Name	Address	ID/FEI	Business Operations
AgroChem Inc		805427700	manufacture(17307-1110)