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NDC 71726-0001-01 bioXterminate Hand Sanitizer Liquid 80 mL/100mL Details

bioXterminate Hand Sanitizer Liquid 80 mL/100mL

bioXterminate Hand Sanitizer Liquid is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by LiquidCapsule Manufacturing LLC. The primary component is ALCOHOL.

Product Information

NDC	71726-0001
Product ID	71726-001_b2912551-7a30-4130-e053-2995a90a4aaf
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	bioXterminate Hand Sanitizer Liquid
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	80
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	LiquidCapsule Manufacturing LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2022-12-31

Package

Package Images

NDC 71726-0001-01 (71726000101)

Pricing Information	N/A
NDC Package Code	71726-001-01
Billing NDC	71726000101
Package	118.3 mL in 1 BOTTLE, PLASTIC (71726-001-01)
Marketing Start Date	2020-05-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a4e1948b-12ed-7c7b-e053-2a95a90a5247 Details

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

in children less than 2 months of age
on open skin wounds

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

SPL UNCLASSIFIED SECTION

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 between 15-30°C (59-86°F)
Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label

1 Gallon (3785 mL) NDC: 71726-001-06

INGREDIENTS AND APPEARANCE

BIOXTERMINATE HAND SANITIZER LIQUID

alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71726-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71726-001-01	118.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/05/2020
2	NDC:71726-001-02	236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/05/2020
3	NDC:71726-001-03	354.9 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/05/2020
4	NDC:71726-001-04	473.2 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/05/2020
5	NDC:71726-001-05	946.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/05/2020
6	NDC:71726-001-06	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/05/2020
7	NDC:71726-001-07	18927 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/05/2020
8	NDC:71726-001-08	208198 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/05/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/05/2020

Labeler - LiquidCapsule Manufacturing LLC (793523890)

Registrant - LiquidCapsule Manufacturing LLC (793523890)

Name	Address	ID/FEI	Business Operations
Establishment
LiquidCapsule Manufacturing LLC		793523890	manufacture(71726-001)

Revised: 10/2020

Document Id: b2912551-7a30-4130-e053-2995a90a4aaf

Set id: a4e1948b-12ed-7c7b-e053-2a95a90a5247

Version: 2

Effective Time: 20201026

Search by Drug Name or NDC

NDC 71726-0001-01 bioXterminate Hand Sanitizer Liquid 80 mL/100mL Details

bioXterminate Hand Sanitizer Liquid 80 mL/100mL

Product Information

Package

Package Images

NDC 71726-0001-01 (71726000101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a4e1948b-12ed-7c7b-e053-2a95a90a5247 Details

Active Ingredient(s)

Purpose

Use

Warnings

Do not use

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Package Label

INGREDIENTS AND APPEARANCE

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