enviropure™ antibacterial hand sanitizer maximum strength (alcohol-free)

SPL v2

SPL

SPL Set ID 76f9a25d-3533-4f7c-a83d-c881a5e80a53

Route

topical

Published

Effective Date 2022-02-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (0.13 mg)

Inactive Ingredients

water urea

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-04-23

Purpose

Antimicrobial and First aid antiseptic

Description

Drug Facts

Medication Information

Warnings

For external use only.

Uses

For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.
For wound sanitizing to help prevent bacterial contamination in cuts, scrapes, burns, lacerations and skin infections.

Purpose

Antimicrobial and First aid antiseptic

Directions

Pump onto hands as needed. Rub briskly together until dry.
Pump onto wounds 3 times a day after cleaning. Allow foam to dissipate. Wipe excess with sterile gauze. May be bandaged once dry.

Inactive Ingredients

ionized water, urea

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

Section 50567-7

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Active Ingredient

Benzalkonium Chloride 0.13%

Principal Display Panel 1 Gal Bottle Label

ENVIROPURE™

ANTIBACTERIAL

HAND

SANITIZER

MAXIMUM STRENGTH

Eliminates 99.99% of Germs

alcohol-free

triclosan-free & fragrance-free

BENZALKONIUM CHLORIDE 0.13%

BAC-D

BACTERIAL DEFENSE_®

128 fl. oz. (1 gal)

Structured Label Content

Warnings

For external use only.

Uses

For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.
For wound sanitizing to help prevent bacterial contamination in cuts, scrapes, burns, lacerations and skin infections.

Purpose

Antimicrobial and First aid antiseptic

Directions

Pump onto hands as needed. Rub briskly together until dry.
Pump onto wounds 3 times a day after cleaning. Allow foam to dissipate. Wipe excess with sterile gauze. May be bandaged once dry.

Inactive Ingredients (Inactive ingredients)

ionized water, urea

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Principal Display Panel 1 Gal Bottle Label (PRINCIPAL DISPLAY PANEL - 1 gal Bottle Label)

ENVIROPURE™

ANTIBACTERIAL

HAND

SANITIZER

MAXIMUM STRENGTH

Eliminates 99.99% of Germs

alcohol-free

triclosan-free & fragrance-free

BENZALKONIUM CHLORIDE 0.13%

BAC-D

BACTERIAL DEFENSE_®

128 fl. oz. (1 gal)

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "urea", "unii": "8W8T17847W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use. For wound sanitizing to help prevent bacterial contamination in cuts, scrapes, burns, lacerations and skin infections.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Discontinue use if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.", "50567-7": "When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.", "Purpose": "Antimicrobial and First aid antiseptic", "Warnings": "For external use only.", "Directions": "Pump onto hands as needed. Rub briskly together until dry. Pump onto wounds 3 times a day after cleaning. Allow foam to dissipate. Wipe excess with sterile gauze. May be bandaged once dry.", "Active ingredient": "Benzalkonium Chloride 0.13%", "Inactive ingredients": "ionized water, urea", "PRINCIPAL DISPLAY PANEL - 1 gal Bottle Label": "ENVIROPURE™ ANTIBACTERIAL HAND SANITIZER MAXIMUM STRENGTH Eliminates 99.99% of Germs alcohol-free triclosan-free & fragrance-free BENZALKONIUM CHLORIDE 0.13% BAC-D BACTERIAL DEFENSE ® 128 fl. oz. (1 gal)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:05.399149 · Updated: 2026-03-14T23:00:23.363901