Fórmula 2 (30,118,236,473,946 mL)

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Nadurtha, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Nadurtha, S.A. de C.V.

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Fórmula 2 (30,118,236,473,946 mL)

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

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

Inactive ingredients

Water, acrylates copolymer, cyclopentasiloxane, aminomethyl propanol, glycerin, hydrogen peroxide, fragrance

Package Label - Principal Display Panel

30 mL NDC: 78270-400-03

118 mL NDC: 78270-400-04

236 mL NDC: 78270-400-05

473mL NDC: 78270-400-06

946 mL NDC: 78270-400-07

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78270-400
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.5 mL  in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)	0.05 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.19 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)	5 g  in 100 mL
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)	0.5 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78270-400-03	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 78270-400-04	188 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 78270-400-05	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 78270-400-06	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 78270-400-07	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	03/30/2020	08/31/2022

Labeler - Nadurtha, S.A. de C.V. (951577590)

Registrant - Nadurtha, S.A. de C.V. (951577590)

Establishment
Name	Address	ID/FEI	Business Operations
Nadurtha, S.A. de C.V.		951577590	manufacture(78270-400) , pack(78270-400) , label(78270-400)

Revised: 11/2023

Document Id: 0a4d7ecb-b4fa-fb59-e063-6394a90addc3

34390-5

Set id: a863992f-68b7-3f20-e053-2a95a90afe81

Version: 3

Effective Time: 20231116