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NDC 50021-0009-01 Hand Sanitizer 70 mL/100mL Details

Hand Sanitizer 70 mL/100mL

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

Product Information

NDC	50021-0009
Product ID	50021-009_f390f62a-562b-472b-ab46-be24c4bd2c99
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	Hand Sanitizer
Proprietary Name Suffix	Zytec Germ Buster
Non-Proprietary Name	Alcohol 70%v/v
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
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 50021-0009-01 (50021000901)

Pricing Information	N/A
NDC Package Code	50021-009-01
Billing NDC	50021000901
Package	100 mL in 1 BOTTLE, PUMP (50021-009-01)
Marketing Start Date	2020-04-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f8f17337-6eac-465f-b961-3fec1c3c0f1f Details

Active Ingredients (v/v )

Ethyl Alcohol 70%

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

• 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 at room temperature 15-30 C (59-86°F).

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

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Aqua (Water), Carbomer, Glycerin, lsopropyl Alcohol, lsopropyl Myristate, Parfum (Fragrance), Polysorbate 20, Propylene Glycol, Tocopheryl Acetate (Vitamin E), Blue 1, Red 40, Yellow 5

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

Zytec Germ Buster Hand Sanitizer Gel

Alcohol Antiseptic 70%

Packge size ranges between 100 ml to 1 Gal

INGREDIENTS AND APPEARANCE

HAND SANITIZER ZYTEC GERM BUSTER

alcohol 70%v/v gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50021-009
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER 940 (UNII: 4Q93RCW27E)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
May contain	LIME (CITRUS) (UNII: 8CZS546954)
May contain	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
May contain	FD&C RED NO. 40 (UNII: WZB9127XOA)
May contain	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50021-009-01	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/24/2020
2	NDC:50021-009-02	240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/24/2020
3	NDC:50021-009-03	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/24/2020
4	NDC:50021-009-04	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/24/2020
5	NDC:50021-009-05	3785 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/24/2020
6	NDC:50021-009-06	240 mL in 1 TUBE; Type 0: Not a Combination Product	05/19/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/24/2020

Labeler - Empack Spraytech Inc. (252047519)

Revised: 5/2020

Document Id: f390f62a-562b-472b-ab46-be24c4bd2c99

Set id: f8f17337-6eac-465f-b961-3fec1c3c0f1f

Version: 2

Effective Time: 20200519