GUSTAR CLEAN WET TISSUE- isopropyl alcohol cloth

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

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Active ingredient:
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
Available from:
GuStar Co., Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic Hand sanitizer to help reduce bacteria on the skin. Only when water and soap is not available.
Authorization status:
OTC monograph not final
Authorization number:
73819-0008-1

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GUSTAR CLEAN WET TISSUE- isopropyl alcohol cloth

GuStar Co., Ltd.

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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ACTIVE INGREDIENT

Isopropyl Alcohol 45%

INACTIVE INGREDIENT

Deionized water

PURPOSE

Antiseptic

WARNINGS

■ For external use only.

■ Flammable. ■ Keep away from heat and Flame.

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When using this product

■ Keep out of eyes, ears and mouth.

■ If contact occurs, rinse eyes thoroughly with water.

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Stop use and ask a doctor

■ If irritation and rash occurs.

KEEP OUT OF REACH OF CHILDREN

■ lf swallowed, get medical help or contact a Poison Control Center right away.

Us es

Hand sanitizer to help reduce bacteria on the skin. Only when water and soap is not available.

Directions

■ Wet hands thoroughly with product and rub hands together until dry.

■ Supervise children under 6 years of age when using.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GUSTAR CLEAN WET TISSUE

isopropyl alcohol cloth

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:738 19 -0 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 .45

Inactive Ingredients

GuStar Co., Ltd.

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:738 19 -0 0 0 8 -1

10 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

12/0 1/20 20

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

12/0 1/20 20

Labeler -

GuStar Co., Ltd. (694234583)

Registrant -

GuStar Co., Ltd. (694234583)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

GuStar Co ., Ltd.

6 9 423458 3

ma nufa c ture (738 19 -0 0 0 8 )

Revised: 12/2020

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