FDA.reportPublic FDA data

Germ Shark PX4 Hand Jumbo Hand Sanitizing Wipes

Manufacturer
Germ Shark LLC
Effective date
2020-08-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:24:51

Label at a glance#

ProductGerm Shark PX4 Hand Jumbo Hand Sanitizing Wipes
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Open box and zipped plastic pouch to thread first wipe (from center of roll) through the hole on top. Don't remove all the wipes. Zip the pouch closed around the wipe. then re-close the box. Gently pull one wipe from the dispenser, pulling at an angle and in a down ward motion. Supervise children under 10 years of age when using this product to avoid swallowing. Let hands completely dry before touching a stove or ...

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethanol Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water USP 18.425%, Glycerin (glycerol) 1.45%, Hydrogen peroxide 0.125%

-ingredients shown refer to liquid portion only, not to wipe fabric material

Use(s)

INDICATIONS & USAGE SECTION

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

-Can be used 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 near sources of ignltion.

Do Not Use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Open box and zipped plastic pouch to thread first wipe (from center of roll) through the hole on top. Don't remove all the wipes.
  • Zip the pouch closed around the wipe. then re-close the box.
  • Gently pull one wipe from the dispenser, pulling at an angle and in a down ward motion.
  • Supervise children under 10 years of age when using this product to avoid swallowing.
  • Let hands completely dry before touching a stove or bbq or coming in close contact with any other open flame.
  • For best results, clean excessively dirty areas before using wipes.
  • Do Not fluh wipes. we recommended that you dispose of them in trash. Flushing wipes can cause damage to plumbing.

Other Information

SPL UNCLASSIFIED SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2361646ethanol 80 % Medicated PadPSN2
2361646ethanol 0.8 ML/ML Medicated PadSCD2
2361646ethanol 80 % Medicated WipesSY2
2361646ethyl alcohol 80 % Topical ClothSY2

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
75158-003-002022-01-28C16284748780-1d6a99b39-adbc-a426-e053-dadaa90af4c2Germ Shark PX4 Hand Jumbo Hand Sanitizing Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75158-003-00Germ Shark PX4 Hand Jumbo Hand Sanitizing Wipes275 in 1 BOXCLOTH2752
75158-003-00Germ Shark PX4 Hand Jumbo Hand Sanitizing Wipes5 mL in 1 PATCHCLOTH52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75158-003GERM SHARK PX4 HAND JUMBO HAND SANITIZING WIPES (ALCOHOL) CLOTH [GERM SHARK LLC]2Legacy NDC, 2 package rows20200817_376f0177-abe4-4e09-9fd3-a8cc49e6da1e.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
75158-00375158-003-00

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
ALCOHOL3K9958V90MACTIB

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
ad0882b8-dc5c-e540-e053-2a95a90ab401376f0177-abe4-4e09-9fd3-a8cc49e6da1e2020-08-16WarningsExact identifier
spl id: ad0882b8-dc5c-e540-e053-2a95a90ab401
spl set id: 376f0177-abe4-4e09-9fd3-a8cc49e6da1e

Reported adverse events (FAERS/openFDA)#

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