Vaporal Hand Sanitizer by Operfel S.A. Vaporal Hand Sanitizer

Drug Details [pdf]

VAPORAL HAND SANITIZER- alcohol gel
Operfel S.A.

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Vaporal Hand Sanitizer

Drug Facts

Active Ingredient(s)

Alcohol 70% v/v

Purpose

Antiseptic

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not able.

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 eye 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 uing this product to avoid swallowing.

Other Information

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

Inactive Ingredients

glycerin, hydrogen peroxide, water, carbomer, triethanolamine.

Package Labeling:60ml

Bottle

Package Labeling:250ml

Bottle2

Package Labeling:500ml

Bottle3

Package Labeling:750ml

Bottle4

Package Labeling:1000ml

Bottle5

Package Labeling:3780ml

Bottle6

VAPORAL HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79980-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 79980-001-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/06/2020	08/07/2020
2	NDC: 79980-001-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/06/2020	08/07/2020
3	NDC: 79980-001-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/06/2020	08/07/2020
4	NDC: 79980-001-04	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/06/2020	08/07/2020
5	NDC: 79980-001-05	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/06/2020	08/07/2020
6	NDC: 79980-001-06	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/06/2020	08/07/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	08/06/2020	08/07/2020

Labeler - Operfel S.A. (935284554)

Revised: 1/2024

Document Id: 0e1197e8-7b5d-14aa-e063-6294a90a9654

Set id: ac893343-e9cc-4f1e-e053-2995a90a41a1

Version: 2

Effective Time: 20240103