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NDC 69335-0002-01 Alpha E-3 Instant Hand Sanitizer 710 g/1000mL Details

Alpha E-3 Instant Hand Sanitizer 710 g/1000mL

Alpha E-3 Instant Hand Sanitizer is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Alpha Chemical Services, Inc.. The primary component is ALCOHOL.

Product Information

NDC	69335-0002
Product ID	69335-002_9d3464ae-4f4e-102b-e053-2995a90af3de
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	Alpha E-3 Instant Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethanol
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	710
Active Ingredient Units	g/1000mL
Substance Name	ALCOHOL
Labeler Name	Alpha Chemical Services, 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 69335-0002-01 (69335000201)

Pricing Information	N/A
NDC Package Code	69335-002-01
Billing NDC	69335000201
Package	3785 mL in 1 BOTTLE, PLASTIC (69335-002-01)
Marketing Start Date	2014-11-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4907b7ff-4e2c-4d24-ab74-030371e82c1c Details

Active Ingredient

Ethanol 71.0%

Purpose

Hand Sanitizer

Uses

Sanitize hands to help reduce bacteria that potentially can cause disease
Helps to prevent cross contamination
Recommended for repeated use
Helps to prevent drying of the skin

Warnings

For external use only
Flammable, keep away from fire or flame

When using this product

Do not use in or near eyes
For external use only
Discontinue use if irritation and redness develop

Keep out of reach of children

In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directons

Wet hands thoroughly with spray, covering entire surface of hands, especially the fingernails and cuticles
Rub hands together until dry

Other information

Store in a cool, dry place below 104° F

Inactive ingredients

water, isopropanol, glycerin, glycerol monolaurate

Questions?

Contact Alpha Chemical Mon-Fri 9am - 4p PST at 800-464-9872

SPL UNCLASSIFIED SECTION

Manufactured for:

Alpha Chemical Services, Inc.

46 Morton St.

Stoughton, MA 02072

www.alphachemical.com

SDS-18-15002

Principal Display Panel

NDC: 69335-002-01

Alpha E-3 Instant Hand Sanitizer Spray

NSF

Nonfood Compounds Program Listed (E2) Registration #

INGREDIENTS AND APPEARANCE

ALPHA E-3 INSTANT HAND SANITIZER

ethanol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69335-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	710 g in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERYL LAURATE (UNII: Y98611C087)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69335-002-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/04/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/04/2014

Labeler - Alpha Chemical Services, Inc. (051782316)

Registrant - Best Sanitizers, Inc (627278224)

Name	Address	ID/FEI	Business Operations
Establishment
Best Sanitizers, Inc		627278224	manufacture(69335-002)

Revised: 1/2020

Document Id: 9d3464ae-4f4e-102b-e053-2995a90af3de

Set id: 4907b7ff-4e2c-4d24-ab74-030371e82c1c

Version: 2

Effective Time: 20200128