HAND SANITIZER- alcohol gel 
Industrias Trevigo, 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

Drug Facts

Active ingredient:

Ethyl Alcohol 70%

Purpose:

Antimicrobial

Use:

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

+ Flammable --- Keep away from fire or flame.
+ For external use only.

When using this product

 + do not use in or near the eyes. In case of contact, rinse eyes throughly 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.

Directions

+ Place product on hands.
+ Rub until dry.

Inactive ingredients:

Water, Carbomer, Glycerin, T.E.A, Benzalkonium chloride, Fragrance ( Parfum ).

Other Information

+ Store below 110ºC ( 43ºF )
+ May discolor certain fabrics or surfaces.

Package Labeling: 236ml

Label1

Package Labeling: 473ml

Label2

Package Labeling: 1L

Label3

Package Labeling: 3.78L

Label4

Package Labeling: 1000L

Label5

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79409-000
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)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79409-000-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
2NDC:79409-000-02473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
3NDC:79409-000-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
4NDC:79409-000-043780 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
5NDC:79409-000-051000000 mL in 1 TANK; Type 0: Not a Combination Product06/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/2019
Labeler - Industrias Trevigo, S.A. de C.V. (589602580)
Establishment
NameAddressID/FEIBusiness Operations
Industrias Trevigo, S.A. de C.V.589602580manufacture(79409-000) , label(79409-000) , pack(79409-000) , transfill(79409-000)

Revised: 7/2020
Document Id: ab33c1d6-5860-777e-e053-2a95a90a61e8
Set id: 64f2dbc3-e226-4534-8fdf-555e8193a12f
Version: 1
Effective Time: 20200724
 
Industrias Trevigo, S.A. de C.V.