Vital Shield 26 Hand Sanitizer Alcohol

Vital Shield 26 Hand Sanitizer Alcohol by

Drug Labeling and Warnings

Vital Shield 26 Hand Sanitizer Alcohol by is a Otc medication manufactured, distributed, or labeled by Mystic INTL, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VITAL SHIELD 26 HAND SANITIZER ALCOHOL- alcohol gel 
Mystic INTL, 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.

----------

Vital Shield 26 Hand Sanitizer Alcohol

Drug Facts

Active ingredient

ETHYL ALCOHOL 70% v/v

Purpose

Antiseptic, Hand Sanitizer.

Use(s)

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

  • in children less than 2 months of age.
  • on open skin wounds.

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 seious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

Water (Aqua), Carbomer, Triethanolamine, Glycerin.

Package Labeling:

Bottle

VITAL SHIELD 26 HAND SANITIZER ALCOHOL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79911-003
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)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79911-003-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/26/202012/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/26/202012/31/2022
Labeler - Mystic INTL, S.A. de C.V. (812840331)

Revised: 12/2021
Document Id: d3b732ab-f4fd-5fd6-e053-2a95a90a88c2
Set id: b12a3bb3-1856-bfea-e053-2a95a90a69d7
Version: 2
Effective Time: 20211222