Natura Antiseptic Hand Gel

Natura Antiseptic Hand Gel by

Drug Labeling and Warnings

Natura Antiseptic Hand Gel by is a Otc medication manufactured, distributed, or labeled by PAPOUTSANIS S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NATURA ANTISEPTIC HAND GEL- alcohol gel 
PAPOUTSANIS S.A.

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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Natura Antiseptic Hand Gel

Drug Facts

Active ingredient[s]

Alcohol 80% 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 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.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years or 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

glycerin, hydrogen peroxide, purified water USP, parfum, aminomethyl propanol, carbomer.

Company Information

PAPOUTSANIS S.A 34100 HALKIDA,

T: +30 22620 85000 - Made in Greece - www.papoutsanis.gr

Distributed by USA: 1796 Clove Rd, Staten Island, NY 10304, US

TEL: 1 718-447-1206

Product Packaging

PAPOUTSANIS

Natura

ANTISEPTIC HAND GEL

Antiseptic Hand Rub

Alcohol

Antiseptic 80%

Topical Solution

Non-sterile Solution

80% v/v ALCOHOL

400ml - 13.5 fl.oz.

NATURA ANTISEPTIC HAND GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79772-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79772-001-01	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/05/2020	08/05/2020

Labeler - PAPOUTSANIS S.A. (728432860)

Revised: 6/2021

Document Id: c47f5f88-ee7e-f77d-e053-2995a90a3b6d

34390-5

Set id: ac201bac-d92d-2378-e053-2995a90adb51

Version: 2

Effective Time: 20210611