HAND SANITIZER- ethyl alcohol liquid

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

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Active ingredient:
Alcohol 80%v/v
Available from:
CJ Spirits LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
In children less than two years of age or on open skin wounds Stop use and ask doctor if irritation or rash occurs Antiseptic Place enough product on your hand to cover all surfaces. Rub hands together until dry
Authorization status:
OTC monograph not final
Authorization number:
73912-100-01, 73912-100-02, 73912-100-03, 73912-100-04, 73912-100-05, 73912-100-06

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HAND SANITIZER- ethyl alcohol liquid

CJ Spirits 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.

----------

Active Ingredients

Alcohol 80%v/v

Do Not Use

In children less than two years of age or on open skin wounds

Warnings

For external use only. Flamable. Keep away from heat or flame

Stop Use

Stop use and ask doctor if irritation or rash occurs

Purpos e

Antiseptic

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Instructions for use

Place enough product on your hand to cover all surfaces. Rub hands together until dry

Keep out of reach of children

Keep out of reach of children.

If swallowed get medical help or contact a poison control center immediately

Other information

Store between 15-30C (59=86F)

Avoid freezing and excessive heat above 40C (104F)

Dosage & Administration

Place enough product on your hand to cover all surfaces. Rub hands together until dry.

Us age

Hand sanitizer to help reduce bacteria that can cause disease. For use when soap and water are not

available

Active Ingredients purpose

Alcohol 80%v/v...........................................................................antiseptic

Uses

Hand sanitizer to help reduce bacteria that can cause disease. For use when soap and water are not

available

Warnings

For external use only. Flamable. Keep away from heat or flame

Do not use

In children less than two years of age

on open skin wounds

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 doctor if irritation or rash occurs

Keep out of reach of children.

If swallowed get medical help or contact a poison control center immediately

Place enough product on your hand 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

Store between 15-30C (59=86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients, glycerin, hydrogen peroxide, purified water USP

HAND SANITIZER

ethyl alcohol liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:739 12-10 0

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

8 0 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V)

4.17 mL in 10 0 mL

GLYCERIN (UNII: PDC6 A3C0 OX)

1.45 mL in 10 0 mL

WATER (UNII: 0 59 QF0 KO0 R)

12.5 mL in 10 0 mL

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:739 12-10 0 -0 1

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/24/20 20

2

NDC:739 12-10 0 -0 2

750 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/24/20 20

3

NDC:739 12-10 0 -0 3

118 .3 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/24/20 20

4

NDC:739 12-10 0 -0 4

148 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/24/20 20

5

NDC:739 12-10 0 -0 5

375 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/24/20 20

6

NDC:739 12-10 0 -0 6

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

0 3/24/20 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

0 3/24/20 20

Labeler -

CJ Spirits LLC (063779302)

Registrant -

CJ Spirits LLC (063779302)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

CJ Spirits LLC

CJ Spirits LLC

0 6 3779 30 2

ma nufa c ture (739 12-10 0 )

Revised: 8/2020

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