Hand Sanitizer by Amenidades de Jalisco S.C. de R.L. de C.V.

Drug Details [pdf]

HAND SANITIZER- alcohol gel
Amenidades de Jalisco S.C. de R.L. de C.V.

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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

Acrylates copolymer, glycerin, triethanolamine (Trolamine), water.

Package Label - Principal Display Panel

250 mL NDC: 78105-002-01

Citrus

Package Label- Principal Display Panel

500 mL NDC: 78105-002-02

Citrus

Package Label- Principal Dispay Panel

NDC: 78105-002-03

Citrus

Package Label-Principal Display Panel

10 mL NDC: 78105-002-05

Citrus

Package Label - Outer Package

500 pieces NDC: 78105-002-04 Outer Package

Citrus

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78105-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	1 mL in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	1.1 mL in 100 mL
WATER (UNII: 059QF0KO0R)	21.4 mL in 100 mL
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)	3.25 mL in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	3.25 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 78105-002-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020	06/15/2022
2	NDC: 78105-002-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020	06/15/2022
3	NDC: 78105-002-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2020	06/15/2022
4	NDC: 78105-002-04	500 in 1 BOX	08/26/2020	06/15/2022
4	NDC: 78105-002-05	10 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M003	06/29/2020	06/15/2022

Labeler - Amenidades de Jalisco S.C. de R.L. de C.V. (813238920)

Registrant - Amenidades de Jalisco S.C. de R.L. de C.V. (813238920)

Name	Address	ID/FEI	Business Operations
Establishment
Amenidades de Jalisco S.C. de R.L. de C.V.		813238920	manufacture(78105-002)

Revised: 10/2023

Document Id: 088fb8fe-6646-ec4e-e063-6394a90af797

Set id: a914f80c-7433-0c71-e053-2a95a90aa6cd

Version: 5

Effective Time: 20231025

Trademark Results [Hand Sanitizer]

Mark Image Registration \| Serial	Company Trademark Application Date
HAND SANITIZER 88958909 not registered Live/Pending	MAISON BLANCHE, LLC 2020-06-10