Hand Sanitizer

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

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Active ingredient:
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
Available from:
CLEANEDGE LLP
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic, Hand Sanitizer Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Authorization status:
OTC monograph not final
Authorization number:
78529-8010-1

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HAND SANITIZER- isopropyl alcohol liquid

CLEANEDGE LLP

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.

----------

Hand Sanitizer

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain

Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance

for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade

ingredients in the preparation of the product (percentage in final product formulation) consistent with

World Health Organization (WHO) recommendations:

a. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco

Tax and Trade Bureau regulations in 27 CFR part 20.

b. Glycerol (1.45% v/v).

c. Hydrogen peroxide (0.125% v/v).

d. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may

impact the quality and potency of the product.

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpos e

Antiseptic, Hand Sanitizer

Us e

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water

are not available.

Warnings

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

Do not use

in children less than 2 months 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 a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

away.

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

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

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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

100 ml NDC: 78529-8010

HAND SANITIZER

isopropyl alcohol liquid

CLEANEDGE LLP

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:78 529 -8 0 10

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

75 mL

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

1.45 mL in 10 0 mL

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

0 .125 mL in 10 0 mL

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:78 529 -8 0 10 -1 10 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/30 /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 3/30 /20 20

Labeler -

CLEANEDGE LLP (003137705)

Registrant -

CLEANEDGE LLP (003137705)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

CLEANEDGE LLP

0 0 313770 5

ma nufa c ture (78 529 -8 0 10 )

Revised: 12/2020

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