Germ Shark Thick Premium Disinfecting Alcohol Hand Wipes 70% Isopropyl Alcohol

Germ Shark Thick Premium Disinfecting Alcohol Hand Wipes 70 Isopropyl Alcohol by

Drug Labeling and Warnings

Germ Shark Thick Premium Disinfecting Alcohol Hand Wipes 70 Isopropyl Alcohol by is a Otc medication manufactured, distributed, or labeled by Germ Shark, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GERM SHARK THICK PREMIUM DISINFECTING ALCOHOL HAND WIPES 70 ISOPROPYL ALCOHOL- isopropyl 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 Thick Premium Disinfecting Alcohol Hand Wipes 70% Isopropyl Alcohol

Drug Facts

Active Ingredients

Isopropyl Alcohol 70% v/v

Purpose

Antiseptic

Inactive Ingredients

Water, Benzalkonium Chloride, Cetylpyridinium Chloride

*Wipe fabric is made of polyester and rayon

• Germ Sharkis registered with the FDA in the United States.

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

Do Not Use

• 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

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

When Using This Product

• Avoid contact with eyes and danaged skin. If contact occurs, rinse thoroughly in running water.
• Stop use and ask a doctor if irritation, redness or rash occurs for Over 72 hours. These may be signs of a serious condition.

Other Information

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

Warnings

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

How to Use:

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, cleun 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 damage in plumbing.

Package Labeling:

GERM SHARK THICK PREMIUM DISINFECTING ALCOHOL HAND WIPES 70 ISOPROPYL ALCOHOL 
isopropyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75158-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75158-008-01	50 in 1 PACKAGE	11/15/2020	01/06/2021
1		7.8 mL in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/15/2020	01/06/2021

Labeler - Germ Shark, LLC (117480758)

Revised: 1/2021

Document Id: b83dcf87-79ff-fc14-e053-2995a90ac620

34390-5

Set id: b5582f24-6da3-450d-e053-2a95a90a7964

Version: 2

Effective Time: 20210106