Hand Sanitizer

Manufacturer
Solquim SA DE CV | Solquim S.A. de C.V.
Effective date
2020-11-14
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-05-31 23:33:44

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

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:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

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 80% 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

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

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

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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Deer Bottle 60mlDeer Bottle 60ml

Arroyo Bottle3 120 mlArroyo Bottle3 120 ml

Arroyo Bottle2 120 mlArroyo Bottle2 120 ml

Arroyo Bottle 120 mlArroyo Bottle 120 ml

Solquim Bottle 500 mlSolquim Bottle 500 ml

Solquim Bottle 120 mlSolquim Bottle 120 ml

Solquim Bottle 60 mlSolquim Bottle 60 ml

Solquim Drum 50000 mlSolquim Drum 50000 ml

Solquim Drum 20000 mlSolquim Drum 20000 ml

Solquim Bottle 4000 mlSolquim Bottle 4000 ml

Solquim Bottle 1000 mlSolquim Bottle 1000 ml

Drum 1000000 mlDrum 1000000 ml

HEY bottlr 120 mlHEY bottlr 120 ml

HEY bottle 4000 mlHEY bottle 4000 ml

HEY bottle 60 mlHEY bottle 60 ml

HEY Bottle 1000 mlHEY Bottle 1000 ml

HEY bottle 500 mlHEY bottle 500 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN16
582753ethanol 70 % Topical SolutionPSN16
581662ethanol 0.7 ML/ML Topical GelSCD16
582753ethanol 0.7 ML/ML Topical SolutionSCD16
581662ethanol 70 % Topical GelSY16
582753ethanol 70 % Topical SolutionSY16
581662ethyl alcohol 70 % Topical GelSY16
582753ethyl alcohol 70 % Topical SolutionSY16

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74161-175-012022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb
74161-175-022022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb
74161-175-032022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb
74161-175-042022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb
74161-175-052022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb
74161-175-062022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb
74161-175-072022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb
74161-175-082022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb
74161-176-022022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb
74161-176-032022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb
74161-176-042022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb
74161-176-052022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb
74161-176-072022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb
74161-177-022022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb
74161-177-032022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb
74161-177-102022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb
74161-177-112022-01-28C16284748780-1d6a99b39-fee5-a426-e053-dadaa90af4c2a2dc681d-ccc0-0a85-e053-2a95a90a90fb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74161-175-01Hand Sanitizer50000 mL in 1 DRUMSOLUTION5000016
74161-175-02Hand Sanitizer60 mL in 1 BOTTLESOLUTION6016
74161-175-03Hand Sanitizer120 mL in 1 BOTTLESOLUTION12016
74161-175-04Hand Sanitizer4000 mL in 1 DRUMSOLUTION400016
74161-175-05Hand Sanitizer1000 mL in 1 BOTTLESOLUTION100016
74161-175-06Hand Sanitizer20000 mL in 1 DRUMSOLUTION2000016
74161-175-07Hand Sanitizer500 mL in 1 BOTTLESOLUTION50016
74161-175-08Hand Sanitizer1000000 mL in 1 DRUMSOLUTION100000016
74161-176-02HAND SANITIZER60 mL in 1 BOTTLESOLUTION6016
74161-176-03HAND SANITIZER120 mL in 1 BOTTLESOLUTION12016
74161-176-04HAND SANITIZER4000 mL in 1 BOTTLESOLUTION400016
74161-176-05HAND SANITIZER1000 mL in 1 BOTTLESOLUTION100016
74161-176-07HAND SANITIZER500 mL in 1 BOTTLESOLUTION50016
74161-177-02HAND SANITIZER60 mL in 1 BOTTLESOLUTION6016
74161-177-03HAND SANITIZER120 mL in 1 BOTTLESOLUTION12016
74161-177-10HAND SANITIZER120 mL in 1 BOTTLESOLUTION12016
74161-177-11HAND SANITIZER120 mL in 1 BOTTLESOLUTION12016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74161-175HAND SANITIZER (ALCOHOL) SOLUTION HAND SANITIZER (ALCOHOL) SOLUTION [SOLQUIM SA DE CV]16Legacy NDC, 8 package rows20201117_a2dc681d-ccc0-0a85-e053-2a95a90a90fb.zip
74161-176HAND SANITIZER (ALCOHOL) SOLUTION HAND SANITIZER (ALCOHOL) SOLUTION [SOLQUIM SA DE CV]16Legacy NDC, 5 package rows20201117_a2dc681d-ccc0-0a85-e053-2a95a90a90fb.zip
74161-177HAND SANITIZER (ALCOHOL) SOLUTION HAND SANITIZER (ALCOHOL) SOLUTION [SOLQUIM SA DE CV]16Legacy NDC, 4 package rows20201117_a2dc681d-ccc0-0a85-e053-2a95a90a90fb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b40b4b58-5d26-596b-e053-2995a90a5baba2dc681d-ccc0-0a85-e053-2a95a90a90fb2020-11-14WarningsExact identifier
spl id: b40b4b58-5d26-596b-e053-2995a90a5bab
spl set id: a2dc681d-ccc0-0a85-e053-2a95a90a90fb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.