FUSONI HAND SANITIZER WITH MOISTURIZER PLUS BLUE- alcohol gel 
FUSONI HAND SANITIZER WITH MOISTURIZER PLUS- alcohol gel 
Fusoni 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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Hand Sanitizer Plus products listing

Active Ingredient

Ethyl alcohol 70% v/v

Purpose

Antimicrobial

Uses

Hand sanitizer to decrease bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

Flammable, keep away from source of heat, fire or flame.
For external use only. Do not inhale or ingest.

When using this product

do not use in or near the eyes; if contact occurs, rinse eyes
thoroughly with water.

avoid contact with broken skin.

Stop use and ask a doctor if

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 immediately.

Directions

place enough product in your palm to thoroughly cover your hands and rub them together until dry.
children under 6 years of age should be supervised when using this product.

Other information

do not store above 109°F (43°C).
may discolor certain surfaces or fabrics.

Inactive ingredients

Product 011 "DRUG FACTS Fusoni Hand Sanitizer Plus.jpg":

Water, Hydroxyethylcellulose, PPG-3 Benzyl Ether Myristate, Citric Acid, Phenoxyethanol, Glycerine, Ammonium Hydroxide.

Product 012 "DRUG FACTS Fusoni Hand Sanitizer Plus Blue.jpg":

Water, Hydroxyethylcellulose, PPG-3 Benzyl Ether Myristate, Citric Acid, Phenoxyethanol, Glycerine, Blue 1, Ammonium Hydroxide.

3.8 L NDC: 79380-011-12 DRUG FACTS Fusoni Hand Sanitizer PlusFront label Fusoni Hand Sanitizer Plus

DRUG FACTS Fusoni Hand Sanitizer Plus BlueFront label Fusoni Hand Sanitizer Plus Blue3.8 L NDC: 79380-012-12

FUSONI HAND SANITIZER WITH MOISTURIZER PLUS BLUE 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79380-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 L  in 1 L
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
AMMONIA (UNII: 5138Q19F1X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79380-012-110.946 L in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
2NDC:79380-012-123.785 L in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
3NDC:79380-012-1318.93 L in 1 PAIL; Type 0: Not a Combination Product07/07/2020
4NDC:79380-012-14208.18 L in 1 DRUM; Type 0: Not a Combination Product07/07/2020
5NDC:79380-012-151003.03 L in 1 CONTAINER; Type 0: Not a Combination Product07/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/07/2020
FUSONI HAND SANITIZER WITH MOISTURIZER PLUS 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79380-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 L  in 1 L
Inactive Ingredients
Ingredient NameStrength
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
AMMONIA (UNII: 5138Q19F1X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79380-011-110.946 L in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
2NDC:79380-011-123.785 L in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
3NDC:79380-011-1318.93 L in 1 PAIL; Type 0: Not a Combination Product07/07/2020
4NDC:79380-011-14208.18 L in 1 DRUM; Type 0: Not a Combination Product07/07/2020
5NDC:79380-011-151003.03 L in 1 CONTAINER; Type 0: Not a Combination Product07/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/07/2020
Labeler - Fusoni S.A. de C.V. (811412535)
Establishment
NameAddressID/FEIBusiness Operations
Fusoni S.A. de C.V.811412535manufacture(79380-011, 79380-012) , pack(79380-011, 79380-012) , label(79380-011, 79380-012)

Revised: 7/2020
Document Id: a9de7fd7-4a75-1df3-e053-2a95a90aebd4
Set id: a9de7fd7-4a74-1df3-e053-2a95a90aebd4
Version: 1
Effective Time: 20200707
 
Fusoni S.A. de C.V.