HAND SANITIZER aerosol, foam

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

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Innovaciones Tecnologicas Concar SA de CV
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:
79279-620-04

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HAND SANITIZER- hand sanitizer aerosol, foam

Innovaciones Tecnologicas Concar SA de CV

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.

----------

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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (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)

Alcohol 80% 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

50 L NDC: 79279-620-04

HAND SANITIZER

hand sanitizer aerosol, foam

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:79 279 -6 20

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

0 .13 kg

in 10 0 L

Innovaciones Tecnologicas Concar SA de CV

UNII:7N6 JUD5X6 Y)

CHLORIDE

in 10 0 L

Inactive Ingredients

Ingredient Name

Stre ng th

HYDRO XYETHYL CELLULO SE, UNSPECIFIED (UNII: T4V6 TWG28 D)

0 .1 L in 10 0 L

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

0 .0 5 L in 10 0 L

LANO LIN (UNII: 7EV6 5EAW6 H)

0 .0 5 L in 10 0 L

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

1.45 L in 10 0 L

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

0 .125 L in 10 0 L

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:79 279 -6 20 -0 4 50 L in 1 CONTAINER; 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 -

Innovaciones T ecnologicas Concar SA de CV (951578588)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Inno vacio nes Tecno lo gicas Co ncar SA de CV

9 51578 58 8

ma nufa c ture (79 279 -6 20 )

Revised: 12/2020

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