CAPIZONNE HAND SANITIZER- alcohol gel 
Food Insixsigma, S.A. de C.V.

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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Capizonne Hand Sanitizer

DRUG FACTS

Active ingredient

Ethyl alcohol 70% v/v

Purpose

Antimicrobial

Use:

Hand sanitizer to help reduce bacteria on the skin.

Warnings

Flamable. Keep away from fire or flame. For external use only. Do not ingest, if swallowed seek medical help. Avoid contact with eyes.

Keep out of reach of children.

Children under 6yrs old to use under adult supervision. In case of irritation, discontinue use and consult your doctor.

Directions:

Apply the Gel on the hands and rub gently for 20 seconds until the product evaporates.

Other information:

Store below 106°F(41°C) May discolor certain fabrics or surfaces.

Inactive ingredients:

demineralized water, glycerin, carbomer, triethanolamine, dmdm hydantoin, aloe barbadensis extract, iodopropynyl butylcarbamate, butylene glycol.

Package Labeling:

Label

CAPIZONNE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80023-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80023-000-01250 mL in 1 POUCH; Type 0: Not a Combination Product07/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/13/2020
Labeler - Food Insixsigma, S.A. de C.V. (812834608)
Establishment
NameAddressID/FEIBusiness Operations
Food Insixsigma, S.A. de C.V.812834608manufacture(80023-000) , label(80023-000) , pack(80023-000)

Revised: 8/2020
Document Id: ae2f9029-a921-dbf7-e053-2a95a90a2ffe
Set id: ae2ee386-9a24-2086-e053-2a95a90a745a
Version: 1
Effective Time: 20200831
 
Food Insixsigma, S.A. de C.V.