HAND SANITIZER GREEN- alcohol gel 
HAND SANITIZER- alcohol gel 
HAND SANITIZER BLUE- alcohol gel 
Grupo Delveg, 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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Gomina Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

For external use only: hands. Flammable. Keep away from fire or flame.

Keep out of eyes, in case of contact, flush thoroughly with water. Avoid contact with broken skin. Do not inhale nor ingest.

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 Poisson Control Center immediately.

Directions

Other information

Inactive ingredients

carbomer, demineralized water, glycerin, Microcare®CB (benzyl alcohol and a mixture of methylchloroisothiazolinone and methylisothiazolinone) and triethanolamine. May contain FD&C Blue No. 1, FD&C Blue No. 2, FD&C Yellow No. 5 (tartrazine) and/or FD&C Yellow No. 6.

Questions? +52 444 823 5650

Label NDC 79008-001

1000 mL NDC: 79008-001-01

Hand Sanitizer Label  Sample

Label NDC: 79008-001-02

220 mL NDC: 79008-001-02

Hand Sanitizer Label  220 ml

Label NDC 79008-001-03

1000 mL NDC: 79008-001-03

Bottle w/dispenser

Hand Sanitizer Label 1 L w/dispenser

Label NDC 79008-002-01

1000 mL NDC: 79008-002-01

Hand Sanitizer Label

Label NDC: 79008-002-02

220 mL NDC: 79008-002-02

Hand Sanitizer Label  220 ml

Label NDC 79008-002-03

1000 mL NDC: 79008-002-03

Bottle w/dispenser

Hand Sanitizer Label 1 L w/dispenser

Label NDC 79008-003-01

1000 mL NDC: 79008-003-01

Hand Sanitizer Label

Label NDC: 79008-003-02

220 mL NDC: 79008-003-02

Hand Sanitizer Label  220 ml

Label NDC 79008-003-03

1000 mL NDC: 79008-003-03

Bottle w/dispenser

Hand Sanitizer Label 1 L w/dispenser

HAND SANITIZER  GREEN
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79008-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79008-002-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/27/2020
2NDC:79008-002-02220 mL in 1 BOTTLE; Type 0: Not a Combination Product09/27/2020
3NDC:79008-002-031000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/27/2020
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79008-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79008-001-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:79008-001-02220 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:79008-001-031000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
HAND SANITIZER  BLUE
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79008-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79008-003-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/27/2020
2NDC:79008-003-02220 mL in 1 BOTTLE; Type 0: Not a Combination Product09/27/2020
3NDC:79008-003-031000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/27/2020
Labeler - Grupo Delveg, S.A. de C.V. (816144521)
Registrant - Grupo Delveg, S.A. de C.V. (816144521)
Establishment
NameAddressID/FEIBusiness Operations
Grupo Delveg, S.A. de C.V.816144521manufacture(79008-001, 79008-002, 79008-003) , pack(79008-001, 79008-002, 79008-003) , label(79008-001, 79008-002, 79008-003)

Revised: 10/2020
Document Id: b0b3a299-1206-39d7-e053-2995a90ac441
Set id: a82495fb-2194-b21c-e053-2a95a90acccf
Version: 3
Effective Time: 20201002
 
Grupo Delveg, S.A. de C.V.