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Santi-Gel Instant Hand Sanitizer

Dosage form: solution
Ingredients: ALCOHOL 62.5mL in 100mL
Labeler: Kutol Products Company, Inc.
NDC Code: 50865-056

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.

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.

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SANTI-GEL INSTANT HAND SANITIZER 
santi-gel instant hand sanitizer solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-056
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL62.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYACRYLIC ACID (250000 MW) 
WATER 
GLYCERIN 
PROPYLENE GLYCOL 
ISOPROPYL MYRISTATE 
AMINOMETHYLPROPANOL 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
Packaging
#Item CodePackage Description
1NDC:50865-056-073785 mL in 1 JUG
2NDC:50865-056-121200 mL in 1 BAG
3NDC:50865-056-19236 mL in 1 BOTTLE, PLASTIC
4NDC:50865-056-30473 mL in 1 BOTTLE, PLASTIC
5NDC:50865-056-34118 mL in 1 BOTTLE, PLASTIC
6NDC:50865-056-35118 mL in 1 BOTTLE, PLASTIC
7NDC:50865-056-65800 mL in 1 BAG
8NDC:50865-056-791892 mL in 1 BOTTLE, PUMP
9NDC:50865-056-82800 mL in 1 BOTTLE
10NDC:50865-056-86800 mL in 1 BAG
11NDC:50865-056-931200 mL in 1 BOTTLE, PLASTIC
12NDC:50865-056-672000 mL in 1 BAG
13NDC:50865-056-361000 mL in 1 BOTTLE, PLASTIC
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/FEIOperations
Kutol Products Company, Inc.004236139manufacture(50865-056), analysis(50865-056), label(50865-056), pack(50865-056)

Revised: 10/2013
 
Kutol Products Company, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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