Dr. Vranjes Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by DR. VRANJES FIRENZE SPA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
DR. VRANJES FIRENZE SPA

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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Dr. Vranjes Hand Sanitizer

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

• 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.

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

Inactive ingredients

purified water USP, glycerin, hydroxypropy methylcellulose, fragrance

Package Label - Principal Display Panel

Dr. Vranjes Firenze

Hand Sanitizer

Non-Sterile Solution

Alcohol antiseptic 70%v/v topical solution

100 mL

NDC: 79330-700-10

NDC: 79339-700-50

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79330-700
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)	2 mL  in 100 mL
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)	1.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79330-700-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020
2	NDC: 79330-700-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/15/2020	10/22/2021

Labeler - DR. VRANJES FIRENZE SPA (435496264)

Revised: 10/2021

Document Id: cf57f6e4-d5f7-b380-e053-2a95a90a4309

34390-5

Set id: aa6956a9-3754-9496-e053-2a95a90ac257

Version: 5

Effective Time: 20211027