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NDC 69335-0001-01 Alpha BAC Stop E-2 1.5 g/100mL Details

Alpha BAC Stop E-2 1.5 g/100mL

Alpha BAC Stop E-2 is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Alpha Chemical Services, Inc.. The primary component is CHLOROXYLENOL.

Product Information

NDC	69335-0001
Product ID	69335-001_9d34a4ae-ab30-7542-e053-2a95a90ae476
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 BAC Stop E-2
Proprietary Name Suffix	n/a
Non-Proprietary Name	CHLOROXYLENOL
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	1.5
Active Ingredient Units	g/100mL
Substance Name	CHLOROXYLENOL
Labeler Name	Alpha Chemical Services, 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 69335-0001-01 (69335000101)

Pricing Information	N/A
NDC Package Code	69335-001-01
Billing NDC	69335000101
Package	3785 mL in 1 BOTTLE, PLASTIC (69335-001-01)
Marketing Start Date	2014-11-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c22e1176-6904-455c-b7cb-3ad40e013807 Details

Active Ingredient

Chloroxylenol (1.50% w/w)

Purpose

Antiseptic Hand Cleanser

Uses

Handwash to help reduce bacteria that potentially can cause diseases
Helps to prevent cross contamination by hand contact
Helps to prevent drying of the skin
Recommended for repated use

Warnings

For external use only

When using this product

Do not use in or near eyes

Keep out of reach of children

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

Directons

Wet hands and forearms
Apply an application to hands and forearms
Scrub thoroughly for at least 30 seconds (include the fingernails and the cuticles)
Rinse

Other information

Store in a cool, dry place below 104° F

Inactive ingredients

water, sodium laureth sulfate, isopropyl alcohol, phenoxyethanol, glycerine, triclosan, TetraSodium EDTA, citric acid

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: 69335-001-01

ALPHA BAC STOP E-2

1.5% PCMX FORMULA

NSF

Nonfood Compounds Program Listed (E2) Registration #

INGREDIENTS AND APPEARANCE

ALPHA BAC STOP E-2

chloroxylenol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69335-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	1.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
TRICLOSAN (UNII: 4NM5039Y5X)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69335-001-01	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	part333A	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(69335-001)

Revised: 1/2020

Document Id: 9d34a4ae-ab30-7542-e053-2a95a90ae476

Set id: c22e1176-6904-455c-b7cb-3ad40e013807

Version: 3

Effective Time: 20200128