VANITIZER I-200- isopropyl alcohol gel 
Vantage Specialties Ingredients, Inc

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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Vanitizer I-200

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Uses

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.

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

Do Not Use

in children less than 2 months of age

on open skin wounds

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

Inactive Ingredients

glycerin, purified water USP, hydroxypropyl cellulose

Keep out of reach of Childern

If swallowed, get medical help or contact a Poison Control Center right away.

Package Label

Vanitizer I-200 1-Gal label

VANITIZER I-200 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47643-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47643-008-013800 mL in 1 JUG; Type 0: Not a Combination Product07/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/24/2020
Labeler - Vantage Specialties Ingredients, Inc (061709127)
Establishment
NameAddressID/FEIBusiness Operations
Vantage Specialty Ingredients, Inc061709127api manufacture(47643-008)

Revised: 10/2020
Document Id: b1cd2f15-dd75-41a1-e053-2a95a90afd56
Set id: ab0ee67f-873f-2803-e053-2995a90a47d6
Version: 2
Effective Time: 20201016
 
Vantage Specialties Ingredients, Inc