GERM SHARK PX4 HAND JUMBO HAND SANITIZING WIPES- alcohol cloth 
Germ Shark LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Germ Shark PX4 Hand Jumbo Hand Sanitizing Wipes

Drug Facts

Active Ingredient(s)

Ethanol Alcohol 80% v/v

Purpose

Antiseptic

Inactive Ingredients

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)

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

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

  • 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

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

Keep out of reach of children.

If eaten,swallowed or chewed get medical help or contact a Poison Control Center right away.

Directions

Other Information

Package Labeling:

Bottle2

GERM SHARK PX4 HAND JUMBO HAND SANITIZING WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75158-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75158-003-00275 in 1 BOX06/03/2020
15 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/03/2020
Labeler - Germ Shark LLC (117480758)

Revised: 8/2020
Document Id: ad0882b8-dc5c-e540-e053-2a95a90ab401
Set id: 376f0177-abe4-4e09-9fd3-a8cc49e6da1e
Version: 2
Effective Time: 20200816
 
Germ Shark LLC