PANITA HAND SANITIZER- alcohol 73% v/v gel

Panita Hand Sanitizer by

Drug Labeling and Warnings

Panita Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Empack Spraytech Inc., Zhejiang Rifeshow Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer rub manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (73%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerin
3. Carbomer
4. Triethanolamine
5. Purfied water

Active Ingredient(s)

Alcohol 73% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Rub

Use

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

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

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

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

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

carbomer, glycerin, triethanolamine , purified water USP

Package Label - Principal Display Panel

3.4 fl.oz. (100 mL) NDC: 50021-010-01

8.1 fi.oz. (240 mL) NDC: 50021-010-02

16.9 fl.oz. (500 mL) NDC: 50021-010-03

INGREDIENTS AND APPEARANCE

PANITA HAND SANITIZER 
alcohol 73% v/v gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50021-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	73 L  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.45   in 100 mL
WATER (UNII: 059QF0KO0R)	25.3 mL  in 100 mL
TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATE (UNII: N2TK31JIAH)	0.25   in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50021-010-01	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020
2	NDC: 50021-010-02	240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020
3	NDC: 50021-010-03	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/01/2020

Labeler - Empack Spraytech Inc. (252047519)

Registrant - Empack Spraytech Inc. (252047519)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Rifeshow Cosmetics Co., Ltd.		560843477	manufacture(50021-010)