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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
Available from:
Germ Shark, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- 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 - 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 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 plumbin
Authorization status:
OTC monograph not final
Authorization number:
75158-008-01

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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

Purpos e

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.

Us es

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

Germ Shark, LLC

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:75158 -0 0 8

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2) (ISOPROPYL ALCOHOL -

UNII:ND2M416 30 2)

ISOPROPYL

ALCOHOL

0 .7 mL in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

CETYLPYRIDINIUM CHLO RIDE (UNII: D9 OM4SK49 P)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:75158 -0 0 8 -0 1

50 in 1 PACKAGE

11/15/20 20

1

7.8 mL in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

11/15/20 20

Labeler -

Germ Shark, LLC (117480758)

Revised: 11/2020

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