Hand Sanitizer 75% v/v Ethanol by Empack Spraytech Inc.

Drug Details [pdf]

HAND SANITIZER 75% V/V ETHANOL PANITA- alcohol gel
Empack Spraytech 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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This is a hand sanitizer Alcohol 75% v/v

Active Ingredient(s)

Alcohol 75% 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

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

Inactive ingredients

Water (Aqua), Glycerin, Carbomer, Aloe Vera Leaf, Carbomer.

Package Label - Principal Display Panel

Hand Sanitizer Gel label 485 ml

Sanitizer Gel

HAND SANITIZER 75% V/V ETHANOL PANITA
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50021-012
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 940 (UNII: 4Q93RCW27E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 50021-012-01	485 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/13/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/13/2020	04/30/2022

Labeler - Empack Spraytech Inc. (252047519)

Revised: 12/2021

Document Id: d3081f63-98ec-d5fe-e053-2995a90a4cdd

Set id: aa5e0aad-75b4-7da1-e053-2995a90a18ce

Version: 2

Effective Time: 20211213