Search by Drug Name or NDC

NDC 79491-0008-01 Vanitizer I-200 70 mL/100mL Details

Vanitizer I-200 70 mL/100mL

Vanitizer I-200 is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Vantage Specialties, Inc.. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	79491-0008
Product ID	79491-008_d58e84a7-1e48-687f-e053-2a95a90a3887
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Vanitizer I-200
Proprietary Name Suffix	n/a
Non-Proprietary Name	Isopropyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Vantage Specialties, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 79491-0008-01 (79491000801)

Pricing Information	N/A
NDC Package Code	79491-008-01
Billing NDC	79491000801
Package	3800 mL in 1 JUG (79491-008-01)
Marketing Start Date	2020-07-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL aa959a49-1727-f7b8-e053-2a95a90a6444 Details

Active Ingredient(s)

Isopropyl 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.

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

SPL UNCLASSIFIED SECTION

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

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

VANITIZER I-200

isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79491-008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYPROPYL CELLULOSE (1200000 WAMW) (UNII: U3JF91U133)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79491-008-01	3800 mL in 1 JUG; Type 0: Not a Combination Product	07/24/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/20/2020

Labeler - Vantage Specialties, Inc. (191349898)

Name	Address	ID/FEI	Business Operations
Establishment
Vantage Specialties, Inc.		191349898	api manufacture(79491-008)

Revised: 1/2022

Document Id: d58e84a7-1e48-687f-e053-2a95a90a3887

Set id: aa959a49-1727-f7b8-e053-2a95a90a6444

Version: 3

Effective Time: 20220114