VanRex Alcohol Antiseptic

VanRex Alcohol Antiseptic by

Drug Labeling and Warnings

VanRex Alcohol Antiseptic by is a Otc medication manufactured, distributed, or labeled by Aromaquest Systems, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VANREX ALCOHOL ANTISEPTIC- alcohol solution 
Aromaquest Systems, 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.

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VanRex Alcohol Antiseptic

Drug Facts

Active Ingredient

Ethyl Alcohol 80% v/v

Purpose

Antiseptic

Uses

Skin rub to help reduce bacteria that potencially can cause disease.

Warning

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 serious condition.

Keep out of reach of children.

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

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

water, isopropyl alcohol.

Package Labeling:475ml

Package Labeling:240ml

Package Labeling:1000ml

Package Labeling:3785ml

VANREX ALCOHOL ANTISEPTIC 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79765-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79765-000-01	475 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020	12/31/2021
2	NDC: 79765-000-02	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020	12/31/2021
3	NDC: 79765-000-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020	12/31/2021
4	NDC: 79765-000-04	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/14/2020	12/31/2021

Labeler - Aromaquest Systems, LLC. (080914413)

Revised: 12/2021

Document Id: d398fa9c-f2eb-7fbc-e053-2995a90a7d3d

34390-5

Set id: acaf3b6a-4e9e-dbe7-e053-2995a90af508

Version: 2

Effective Time: 20211220