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NDC 50021-0007-01 Foam Hand Sanitizer 70 mL/100mL Details

Foam Hand Sanitizer 70 mL/100mL

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

Product Information

NDC	50021-0007
Product ID	50021-007_318a18b8-327f-49ff-b339-57eab73a5620
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	Foam Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol 70%
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, FOAM
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	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50021-0007-01 (50021000701)

Pricing Information	N/A
NDC Package Code	50021-007-01
Billing NDC	50021000701
Package	117 mL in 1 CAN (50021-007-01)
Marketing Start Date	2020-04-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1353660d-a317-4aee-966f-2c1bf829efad 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). May stain surfaces and fabrics.

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

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Aqua, Bis-PEG-12 Dimethicone, Ceteareth-25, Glycerin, Isobutane, Stearyl alcohol.

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 - Foaming Hand Sanitizer

Foaming Hand Sanitizer

Alcohol Antiseptic 70%

Optional size ranges between 100g to 325g

INGREDIENTS AND APPEARANCE

FOAM HAND SANITIZER

alcohol 70% aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50021-007
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
GLYCERIN (UNII: PDC6A3C0OX)	0.07 mL in 100 mL
WATER (UNII: 059QF0KO0R)	27.7 g in 100 mL
CETEARETH-25 (UNII: 8FA93U5T67)	2.45 g in 100 mL
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)	1.96 g in 100 mL
BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4)	1.27 g in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.01 g in 100 mL
ISOBUTANE (UNII: BXR49TP611)	9 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50021-007-01	117 mL in 1 CAN; Type 0: Not a Combination Product	04/07/2020
2	NDC:50021-007-02	381 mL in 1 CAN; Type 0: Not a Combination Product	04/07/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/07/2020

Labeler - Empack Spraytech Inc. (252047519)

Revised: 4/2020

Document Id: 318a18b8-327f-49ff-b339-57eab73a5620

Set id: 1353660d-a317-4aee-966f-2c1bf829efad

Version: 1

Effective Time: 20200407