HAND SANITIZER- alcohol gel 
Vita Viridens, 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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Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

gene

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75610-532
Route of AdministrationTOPICAL, CUTANEOUS
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) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75610-532-48250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:75610-532-045000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:75610-532-121000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:75610-532-60500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:75610-532-373785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Vita Viridens, S.A. de C.V. (951576554)
Registrant - Vita Viridens, S.A. de C.V. (951576554)

Revised: 1/2021
Document Id: b8f160fc-e5a1-9cbd-e053-2995a90ac7f1
Set id: a3a5b007-4d42-4f81-e053-2a95a90a3dcc
Version: 7
Effective Time: 20210115
 
Vita Viridens, S.A. de C.V.