VITAL by AZURE BOTTLING LLC / ARROPOL Chemicals, Inc VITAL

VITAL by

Drug Labeling and Warnings

VITAL by is a Otc medication manufactured, distributed, or labeled by AZURE BOTTLING LLC, ARROPOL Chemicals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VITAL- alcohol gel 
AZURE BOTTLING LLC

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

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

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

If rash or irritation occurs, stop use and consult a doctor. 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 IMMEDIATELY.

if rash or irritation occurs, stop use and consult a doctor . These may be signs of a serious condition.

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

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 59 - 86F/15 - 30C
• Avoid freezing and excessive heat above 104F/40C

Inactive ingredients

glycerin, carbomer, triethanolamine, purified water USP

Package Label - Principal Display Panel

354 mL NDC: 79286-268-12

500 mL NDC: 79286-268-16

1000 mL NDC: 79286-268-11

3785 mL NDC: 79286-268-01

VITAL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79286-268
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79286-268-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/21/2020
2	NDC: 79286-268-16	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/21/2020
3	NDC: 79286-268-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/21/2020
4	NDC: 79286-268-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/21/2020	12/31/2021

Labeler - AZURE BOTTLING LLC (624193384)

Registrant - ARROPOL Chemicals, Inc (007806457)

Establishment
Name	Address	ID/FEI	Business Operations
ARROPOL Chemicals, Inc		007806457	manufacture(79286-268)

Revised: 1/2022

Document Id: d578958e-afa4-e849-e053-2a95a90a15fc

34390-5

Set id: afd3d4ed-4dd3-735d-e053-2a95a90a453f

Version: 2

Effective Time: 20220113