ACTIVE BARRIER ADVANCED HAND SANITIZER- alcohol gel
Pronova Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE BARRIERTM ADVANCED HAND SANITIZER

Drug Facts

Active Ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Use: Hand Sanitizer to help reduce bacteria on the skin.

Warnings: For external use only.

FLAMMABLE. Keep away from flame or high heat.

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and consult a physician if irritation and redness develop.

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Directions: Apply a dime-sized portion to hands, rub to distribute. Allow to dry.

Other information: Store below 110°F (43°C)

May discolor certain fabrics or surfaces.

Inactive Ingredients: Methylcellulose, Acrylates/Octalacrylamide Copolymer, Aminomethyl propanol, Water, Isopopanol, Aloe Barbadensis Leaf Juice, Caprylyl Glycol Glycerin, Isopropyl Myristate, Tocopheryl Acetate.

Questions: (866) 703-3508

70% ETHYL ALCOHOL

SPECIFICALLY FORMULATED FOR HEALTH CARE PROFESSIONALS

MOISTURIZERS & EMOLLIENTS

ALOE VERA & VITAMIN E

CHG COMPATIBLE

KILLS MORE THAN 99.9% OF GERMS

MADE IN USA

Manufactured in the USA for:

Active Barrier LLC. Scituate, MA 02066

www.activebarrier.net

Distributed by:

Pronova Corporation Miami, FL 355155

Packaging

image description

Actv1g

ACTIVE BARRIER ADVANCED HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67555-168
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
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67555-168-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2020	05/31/2022
2	NDC:67555-168-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/25/2020	05/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/25/2020	05/31/2022

Labeler - Pronova Corporation (111421496)

Revised: 5/2023

Document Id: 0cc09f0d-f8d4-4e3f-a603-db6b34844200

Set id: d00b02f4-4cce-4ed9-b889-5903da6027f4

Version: 3

Effective Time: 20230526

Pronova Corporation