FDA.reportPublic FDA data

Wise shield

Manufacturer
INGENIERIA QUIMICA COMERCIAL S DE RL DE CV
Effective date
2020-10-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:34

Label at a glance#

ProductWise shield
Active ingredientISOPROPYL ALCOHOL
Label structure12 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% 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

Alpha-tecopherol, aminomethyl propanol, carbomer 940, glutaral, glycerin and water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 ml NDC: 80885-001-01 PDP 500 mlPDP 500 ml

3800 ml NDC: 80885-001-02 PDP 3800 mlPDP 3800 ml

19000 ml NDC: 80885-001-03 PDP 19000 mlPDP 19000 ml

200000 ml NDC: 80885-001-04 PDP 200000 mlPDP 200000 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2285607isopropyl alcohol 75 % Topical GelPSN1
2285607isopropyl alcohol 0.75 ML/ML Topical GelSCD1
2285607isopropyl alcohol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80885-001-012023-01-30C16284748780-1f386c64a-2a47-0266-e053-dadaa90a7c1ab28b8751-ce11-fade-e053-2995a90a766e
80885-001-022023-01-30C16284748780-1f386c64a-2a47-0266-e053-dadaa90a7c1ab28b8751-ce11-fade-e053-2995a90a766e
80885-001-032023-01-30C16284748780-1f386c64a-2a47-0266-e053-dadaa90a7c1ab28b8751-ce11-fade-e053-2995a90a766e
80885-001-042023-01-30C16284748780-1f386c64a-2a47-0266-e053-dadaa90a7c1ab28b8751-ce11-fade-e053-2995a90a766e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80885-001-01Wise shield500 mL in 1 BOTTLEGEL5001
80885-001-02Wise shield3800 mL in 1 BOTTLEGEL38001
80885-001-03Wise shield19000 mL in 1 BOTTLEGEL190001
80885-001-04Wise shield200000 mL in 1 CONTAINERGEL2000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80885-001WISE SHIELD (ISOPROPYL ALCOHOL) GEL [INGENIERIA QUIMICA COMERCIAL S DE RL DE CV]1Legacy NDC, 4 package rows20201029_b28b8751-ce11-fade-e053-2995a90a766e.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80885-00180885-001-01, 80885-001-02, 80885-001-03, 80885-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
GLUTARALT3C89M417NIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
ALPHA-TOCOPHEROLH4N855PNZ1IACT
AMINOMETHYL PROPANEDIOLCZ7BU4QZJZIACT
CARBOMER 9404Q93RCW27EIACT

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
b28b86c3-1adf-adbc-e053-2a95a90ac710b28b8751-ce11-fade-e053-2995a90a766e2020-10-25WarningsExact identifier
spl id: b28b86c3-1adf-adbc-e053-2a95a90ac710
spl set id: b28b8751-ce11-fade-e053-2995a90a766e

Reported adverse events (FAERS/openFDA)#

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