SANTI-GEL INSTANT HAND SANITIZER- santi-gel instant hand sanitizer solution 
Kutol Products Company, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Santi-Gel Instant Hand Sanitizer

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.

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

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

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

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.

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

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.

50865-056-65.jpg 50865-056-65.jpg

SANTI-GEL INSTANT HAND SANITIZER 
santi-gel instant hand sanitizer solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-056
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50865-056-121200 mL in 1 BAG; Type 0: Not a Combination Product05/22/201305/10/2017
2NDC:50865-056-19236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2013
3NDC:50865-056-30473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2013
4NDC:50865-056-34118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2013
5NDC:50865-056-35118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2013
6NDC:50865-056-65800 mL in 1 BAG; Type 0: Not a Combination Product05/22/201305/10/2017
7NDC:50865-056-791892 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/22/2013
8NDC:50865-056-82800 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/201307/17/2016
9NDC:50865-056-86800 mL in 1 BAG; Type 0: Not a Combination Product05/22/201307/19/2016
10NDC:50865-056-931200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/201305/10/2017
11NDC:50865-056-361000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2013
12NDC:50865-056-66800 mL in 1 BAG; Type 0: Not a Combination Product05/10/2017
13NDC:50865-056-03208175 mL in 1 DRUM; Type 0: Not a Combination Product05/15/2015
14NDC:50865-056-38800 mL in 1 BAG; Type 0: Not a Combination Product05/10/2017
15NDC:50865-056-43236 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
16NDC:50865-056-073875 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
17NDC:50865-056-672000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/22/2013
Labeler - Kutol Products Company, Inc. (004236139)
Registrant - Kutol Products Company, Inc. (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company004236139manufacture(50865-056)

Revised: 8/2023
Document Id: 03a904f5-0643-f1e2-e063-6294a90af80e
Set id: f5bb2593-e036-4586-a807-2049e06b2475
Version: 12
Effective Time: 20230824
 
Kutol Products Company, Inc.