FDA.reportPublic FDA data

ISOPROPYL ALCOHOL

Manufacturer
Germ Shark, LLC
Effective date
2020-10-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:13

Label at a glance#

ProductGerm Shark PX3 Thick Premium Disinfecting Alcohol Hand Wipes 70 Isopropyl Alcohol
Active ingredientISOPROPYL ALCOHOL
Label structure7 sections

Indications and uses

Hand wipes to help reduce bacteria that can potentially cause sickness and disease. For use when soap & water are not available. Intended for use on hands, arms and legs

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Benzalkonium Chloride, Cetylpyridinium Chloride

* Wipe fabric is made of polyester and rayon

  • Germ Shark is registered with the FDA in the United States.

Uses

INDICATIONS & USAGE SECTION

  • Hand wipes to help reduce bacteria that can potentially cause sickness and disease. For use when soap & water are not available.
  • Intended for use on hands, arms and legs

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame. Use in a well-ventilated area and avoid using near sources of ignition.

Do Not Use

OTC - DO NOT USE SECTION

  • on children under 2 months of age - supervise all use by children 
  • on open skin wounds - keep out of reach of children and pets
  • for a personal hygiene or as a make-up removing or baby wipe

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If eaten, swallowed or chewed get medical help or contact a Poison Control center right away (Poison Control in USA: 1-800-222-1222)

When Using This Product

OTC - WHEN USING SECTION

  • Avoid contact with eyes and damaged skin, If contact, occurs, rinse thoroughly in running water.

Stop use and ask a doctor 

OTC - STOP USE SECTION

if irritation, redness or rash occurs for over 72 hours, These may be signs of a serious condition.

Other Information

SPL UNCLASSIFIED SECTION

  • Avoid freezing and excessive heat above 40C (104F)
  • Store between 15-30C (59-86F)
  • Keep away from direct sunlight, heat and flames

How to Use:

DOSAGE & ADMINISTRATION SECTION

Peel back top cover and remove protective film to access the wipes. Locate the wipe at the center of the roll and insert its corner through the opening of the cap. Do NOT push your fingers through the opening. Replace the cover and snap lid securely shut. Pull each wipe with a little force. To keep wipes fresh and moist, close lid after use.

Wipe your hands thoroughly and let dry. Let hands completely dry before coming in close contact with any open flame.

For best results, clean excessively dirty areas before using wipes.

Please do not flush these wipes. We recommend that you dispose of them in the trash. Flushing wipes can cause damaged in plumbing.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN1
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD1
797544isopropyl alcohol 70 % Medicated PadSY1
797544isopropyl alcohol 70 % Topical ClothSY1
797544isopropyl alcohol 70 % Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75158-007-012022-01-28C16284748780-1d6a99b39-4980-a426-e053-dadaa90af4c2Germ Shark PX3 Thick Premium Disinfecting Alcohol Hand Wipes 70% Isopropyl Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75158-007-01Germ Shark PX3 Thick Premium Disinfecting Alcohol Hand Wipes 70 Isopropyl Alcohol105 in 1 CANISTERCLOTH1051
75158-007-01Germ Shark PX3 Thick Premium Disinfecting Alcohol Hand Wipes 70 Isopropyl Alcohol4 mL in 1 PATCHCLOTH41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75158-007GERM SHARK PX3 THICK PREMIUM DISINFECTING ALCOHOL HAND WIPES 70 ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) CLOTH [GERM SHARK, LLC]1Legacy NDC, 2 package rows20201022_b1a1699e-8f96-9670-e053-2a95a90a09d0.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75158-00775158-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
b1a168e4-bf8c-95ef-e053-2a95a90a574ab1a1699e-8f96-9670-e053-2a95a90a09d02020-10-14WarningsExact identifier
spl id: b1a168e4-bf8c-95ef-e053-2a95a90a574a
spl set id: b1a1699e-8f96-9670-e053-2a95a90a09d0

Reported adverse events (FAERS/openFDA)#

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