GEL HAND SANITIZER- 70% ethyl alcohol gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
CORECHEM Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Antiseptic, Hand Sanitizer Use Hand sanitizer to decrease bacteria on the skin that could cause disease. For use when soap and water are not available. Do not use • on children less than 2 months of age • on open skin wounds Stop use Stop use and ask a doctor if irritation or rash occurs and lasts.
Authorization status:
OTC monograph not final
Authorization number:
75029-152-01, 75029-152-31

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GEL HAND SANITIZER- 70% ethyl alcohol gel

CORECHEM Inc.

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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Anitized - Gel Hand Sanitizer - Original - 70% Ethyl Alcohol

Active Ingredient

Active Ingredient

Ethyl alcohol 70% v/v

Purpos e

Purpose

Antiseptic, Hand Sanitizer

Us e

Hand sanitizer to decrease bacteria on the skin that could cause disease.

For use when soap and water are not available.

Warnings

For external use only: hands

Flammable. Keep away from heat or flame.

Do not use

Do not use

on children less than 2 months of age

on open skin wounds

When using

When using

When using this product keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

Stop use

Stop use

Stop use and ask a doctor if irritation or rash occurs and lasts.

Keep out of reach of children

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

Directions

Place enough product on hands to cover all surfaces.

Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Other information

Do not store above 115°F

May discolor some fabrics.

May damage wood finishes or plastics.

Inactive ingredients

Inactive ingredients

Fragrance, Glycerin, isopropyl alcohol, PEG-6 (and) AMP-acrylates/vinyl isodecanoate crosspolymer,

purified water

Package label

Anitized - Hand Sanitizer Gel - Original - 4oz (118 mL) - 20201116 NDC 75029-152-01

Anitized - Hand Sanitizer Gel - Original - 128oz (3.875L) - 20201116 NDC 75029-152-30

GEL HAND SANITIZER

70% ethyl alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:750 29 -152

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

70 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

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

RAPIDGEL EZ1 (UNII: 33JH4A7R2K)

Packag ing

CORECHEM Inc.

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:750 29 -152-

118 mL in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n

Pro duc t

12/0 8 /20 20

2

NDC:750 29 -152-

378 5 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

12/0 8 /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 rt333A

12/0 8 /20 20

Labeler -

CORECHEM Inc. (070056445)

Revised: 12/2020

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