Santi-Gel Instant Hand Sanitizer Solution [Kutol Products Company, Inc.] -

SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.]
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NDC	50865-056-07, 50865-056-12, 50865-056-19, 50865-056-30, 50865-056-34, 50865-056-35, 50865-056-36, 50865-056-65, 50865-056-67, 50865-056-79, 50865-056-82, 50865-056-86, 50865-056-93
Set ID	f5bb2593-e036-4586-a807-2049e06b2475
Category	HUMAN OTC DRUG LABEL
Packager	Kutol Products Company, Inc.
Generic Name
Product Class
Product Number
Application Number	PART333A

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50865-056-12	1200 mL in 1 BAG; Type 0: Not a Combination Product	05/22/2013	05/10/2017
2	NDC:50865-056-19	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2013
3	NDC:50865-056-30	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2013
4	NDC:50865-056-34	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2013
5	NDC:50865-056-35	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2013
6	NDC:50865-056-65	800 mL in 1 BAG; Type 0: Not a Combination Product	05/22/2013	05/10/2017
7	NDC:50865-056-79	1892 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/22/2013
8	NDC:50865-056-82	800 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2013	07/17/2016
9	NDC:50865-056-86	800 mL in 1 BAG; Type 0: Not a Combination Product	05/22/2013	07/19/2016
10	NDC:50865-056-93	1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2013	05/10/2017
11	NDC:50865-056-36	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2013
12	NDC:50865-056-66	800 mL in 1 BAG; Type 0: Not a Combination Product	05/10/2017
13	NDC:50865-056-03	208175 mL in 1 DRUM; Type 0: Not a Combination Product	05/15/2015
14	NDC:50865-056-38	800 mL in 1 BAG; Type 0: Not a Combination Product	05/10/2017
15	NDC:50865-056-43	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020
16	NDC:50865-056-07	3875 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019
17	NDC:50865-056-67	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019

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

Labeler - Kutol Products Company, Inc. (004236139)

Registrant - Kutol Products Company, Inc. (004236139)

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

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SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.]

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