SANTI-GEL INSTANT HAND SANITIZER solution

Santi-Gel Instant Hand Sanitizer by

Drug Labeling and Warnings

Santi-Gel Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kutol Products Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

Flammable. Keep away from heat or flame.

For external use only.

Do not use in the eyes. In case of contact, immediately flush with water.

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

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

ACTIVE INGREDIENT

Ethyl Alcohol 62% v/v.........Antibacterial Agent

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. 

INACTIVE INGREDIENT

Water, Glycerin, Propylene Glycol, Isopropyl Mryistate, Aloe Barbadensis leaf, Tocopheryl Acetate (Vitamin E), Carbomer, Aminomethyl Propanol

DOSAGE & ADMINISTRATION

To decrease bacteria on skin, apply a small amount to palm. Briskly rub, covering hands with product until dry.

Children under 6 years of age should be supervised when using this product.

PURPOSE

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

INDICATIONS & USAGE

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

Do not use in the eyes. In case of contact, immediately flush with water.

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

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

PRINCIPAL DISPLAY PANEL

50865-056-65.jpg

INGREDIENTS AND APPEARANCE

SANTI-GEL INSTANT HAND SANITIZER 
santi-gel instant hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50865-056
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50865-056-07	3785 mL in 1 JUG; Type 0: Not a Combination Product	05/22/2013
2	NDC: 50865-056-12	1200 mL in 1 BAG; Type 0: Not a Combination Product	05/22/2013	05/10/2017
3	NDC: 50865-056-19	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2013
4	NDC: 50865-056-30	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2013
5	NDC: 50865-056-34	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2013
6	NDC: 50865-056-35	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2013
7	NDC: 50865-056-65	800 mL in 1 BAG; Type 0: Not a Combination Product	05/22/2013	05/10/2017
8	NDC: 50865-056-79	1892 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/22/2013
9	NDC: 50865-056-82	800 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2013	07/17/2016
10	NDC: 50865-056-86	800 mL in 1 BAG; Type 0: Not a Combination Product	05/22/2013	07/19/2016
11	NDC: 50865-056-93	1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2013	05/10/2017
12	NDC: 50865-056-67	2000 mL in 1 BAG; Type 0: Not a Combination Product	05/22/2013
13	NDC: 50865-056-36	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2013
14	NDC: 50865-056-66	800 mL in 1 BAG; Type 0: Not a Combination Product	05/10/2017
15	NDC: 50865-056-03	208175 mL in 1 DRUM; Type 0: Not a Combination Product	05/15/2015
16	NDC: 50865-056-38	800 mL in 1 BAG; Type 0: Not a Combination Product	05/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/22/2013

Labeler - Kutol Products Company, Inc. (004236139)

Registrant - Kutol Products Company, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company, Inc.		004236139	manufacture(50865-056) , analysis(50865-056) , label(50865-056) , pack(50865-056)