HAND SANITIZER GEL- alcohol solution

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]

Active Ingredient(s)

Ethyl alcohol 70% v/v

Purpose

Antiseptic, Hand SanitizerAntimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin that could cause disease Recommended for repeated use.

Warnings

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

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Directions

Place enough product in your palm to thoroughly cover your hands Rub hands together briskly until dry

No rinsing required

No towels needed.

Other information

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

Inactive ingredients

Water (Aqua), Aloe Vera, Propylene Glycol, Carboxethyl Acrylate Crosspolymer, Fragrance, FD&C Blue #1, FD&C Yellow #5

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.

Package Label - Principal Display Panel

3780 mL NDC: 17307-1115-3

INGREDIENTS AND APPEARANCE

HAND SANITIZER GEL 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17307-1115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HEPTANAL (UNII: 92N104S3HF)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17307-1115-1	470 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/27/2020
2	NDC: 17307-1115-2	940 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
3	NDC: 17307-1115-3	3780 mL in 1 JUG; Type 0: Not a Combination Product	04/27/2020
4	NDC: 17307-1115-4	18927 mL in 1 DRUM; Type 0: Not a Combination Product	04/27/2020
5	NDC: 17307-1115-5	56781 mL in 1 DRUM; Type 0: Not a Combination Product	04/27/2020
6	NDC: 17307-1115-6	208198 mL in 1 DRUM; Type 0: Not a Combination Product	04/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/27/2020

Labeler - AgroChem Inc (805427700)

Registrant - AgroChem Inc (805427700)

Establishment
Name	Address	ID/FEI	Business Operations
AgroChem Inc		805427700	manufacture(17307-1115)