FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Cosquim S.A. de C.V.
Effective date
2020-09-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:40

Key Label Information#

Active Ingredients And Purpose

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Uses

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Directions And Dosage

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 Label Information

Other information

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

Inactive ingredients

Purified water USP, glycerin, carbomer, fragrance, triethalonamine.

Package Label - Principal Display Panel

​1000 mL NDC: 80215-001-01 250 mL NDC: 80215-001-02

Label Images#

GEL ANTIBACTERIAL 1 L - CDER
GEL ANTIBACTERIAL 1 L - CDER
GEL ANTIBACTERIAL 250 mL - CDER
GEL ANTIBACTERIAL 250 mL - CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80215-001-012022-01-28C16284748780-1d6a99b39-6256-a426-e053-dadaa90af4c2HAND SANITIZER
80215-001-022022-01-28C16284748780-1d6a99b39-6256-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80215-001-01Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICGEL10001
80215-001-02Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80215-001HAND SANITIZER (ALCOHOL) GEL [COSQUIM S.A. DE C.V.]1Legacy NDC, 2 package rows20201001_b079b8cd-dc8a-91ee-e053-2995a90aae41.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80215-00180215-001-01, 80215-001-02

Ingredients#

Name, UNII, Kind table
NameUNIIKind
TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE)36YHT392IDIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
BENZYL SALICYLATEWAO5MNK9TUIACT
ETHYL LINALOOLSF2JS9GF5TIACT
CYCLOHEXYL CINNAMATE2955WP594OIACT
LIMONENE, (+)-GFD7C86Q1WIACT
.BETA.-CITRONELLOL, (+/-)-565OK72VNFIACT

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . The hand sanitizer is 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: Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Sterile distilled water or boiled cold water. Glycerin Carbomer Fragrance Triethanolamine The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

in children less than 2 months of age on open skin wounds

OTC - WHEN USING SECTION

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water USP, glycerin, carbomer, fragrance, triethalonamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​1000 mL NDC: 80215-001-01 250 mL NDC: 80215-001-02

Source Document#

Source XML