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NDC 50021-0008-03 Extra Stength Hand Sanitizer 80 g/100g Details

Extra Stength Hand Sanitizer 80 g/100g

Extra Stength Hand Sanitizer is a TOPICAL AEROSOL, SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Empack Spraytech Inc.. The primary component is ALCOHOL.

Product Information

NDC	50021-0008
Product ID	50021-008_2c4e6146-26c8-4bce-a711-db76332caa8a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Extra Stength Hand Sanitizer
Proprietary Name Suffix	Zytec Germ Buster
Non-Proprietary Name	Alcohol 80%w/w
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, SPRAY
Route	TOPICAL
Active Ingredient Strength	80
Active Ingredient Units	g/100g
Substance Name	ALCOHOL
Labeler Name	Empack Spraytech Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50021-0008-03 (50021000803)

Pricing Information	N/A
NDC Package Code	50021-008-03
Billing NDC	50021000803
Package	125 g in 1 CAN (50021-008-03)
Marketing Start Date	2020-04-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL da854195-3a50-4fae-a5ea-183bf524c973 Details

Active Ingredients (w/w )

Ethyl Alcohol 80%

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduces bacteria that potentially can cause disease. Recommended for repeated use. For use when soap and

water are not available

Warnings

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

Do not use

in children less than 2 months age

on open skin wounds

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes, ears, and mouth. in case of contact with eyes, rinse with water

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

Directions

Hold can at 10 inches distance
Spray 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 at room temperature 15-30 C (59-86°F). May stain surfaces and fabrics.

Avoid freezing and extrensive heat avbove 40C (104F)

Inactive Ingredients

Water (Aqua), Isobutane, Fragrance (Parfum).

Questions ?

1-866-923-2665

Manufactured in Canada by Empack Spraytech Inc., 98 Walker Drive, Brampton, ON, L6T 4H6

UPC Please recycle (+ logo) Lot # and Expiry Date to be embossed on the tube seal

Principal Display Panel -

Extra Stength Hand Sanitizer Spray

Alcohol Antiseptic 80%

Packge size ranges between 51g (100 ml) to 252g (500 ml)

INGREDIENTS AND APPEARANCE

EXTRA STENGTH HAND SANITIZER ZYTEC GERM BUSTER

alcohol 80%w/w aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50021-008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
LIME (CITRUS) (UNII: 8CZS546954)
ISOBUTANE (UNII: BXR49TP611)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50021-008-01	51 g in 1 CAN; Type 0: Not a Combination Product	04/08/2020
2	NDC:50021-008-02	100 g in 1 CAN; Type 0: Not a Combination Product	04/08/2020
3	NDC:50021-008-03	125 g in 1 CAN; Type 0: Not a Combination Product	04/08/2020
4	NDC:50021-008-04	200 g in 1 CAN; Type 0: Not a Combination Product	04/08/2020
5	NDC:50021-008-05	253 g in 1 CAN; Type 0: Not a Combination Product	04/08/2020
6	NDC:50021-008-06	400 g in 1 CAN; Type 0: Not a Combination Product	04/08/2020
7	NDC:50021-008-07	70 g in 1 CAN; Type 0: Not a Combination Product	04/15/2020
8	NDC:50021-008-08	352 g in 1 CAN; Type 0: Not a Combination Product	04/15/2020
9	NDC:50021-008-09	176 g in 1 CAN; Type 0: Not a Combination Product	04/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/08/2020

Labeler - Empack Spraytech Inc. (252047519)

Revised: 4/2020

Document Id: 2c4e6146-26c8-4bce-a711-db76332caa8a

Set id: da854195-3a50-4fae-a5ea-183bf524c973

Version: 5

Effective Time: 20200423