SPL v3
SPL
SPL Set ID b4e1760a-fbfd-6943-e053-2a95a90ac952
Route
TOPICAL
Published
Effective Date 2020-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Lactic Acid Edetate Sodium Peg-7 Glyceryl Cocoate Sodium Benzoate Phenoxyethanol Water Cocamidopropyl Betaine Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-11-24

Description

Benzalkonium chloride 0.13%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium chloride 0.13%

Uses

For hand sanitizing to decrease bacteria on the skin

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

Stop use and ask a doctor

  • if irritation or redness develops
  • condition persists for more than 72 hours
Section 50567-7

When using this product avoid contact with eyes.

If contact occurs, rinse eyes thoroughly with water.

Section 51945-4

For

sensitive

skin

0% Alcohol

aeris

guard

ACTISAN

Hand Sanitizer

Complies with EN-13727-Bactericidal test

For sensitive skin Leaves soft skin feel

Contains moisturizer and emollient Mild and skin compatible

Non-tacky

Active moisturizer

Fragrance free and pH balanced

ALCOHOL

FREE

NET CONTENTS

3.5 fl. oz. (103mL)

Warnings

For External use only

Directions
  • Apply enough product to cover hands
  • Rub together until dry without wiping
Other Information

Store at room temperature

Active Ingredients

Benzalkonium chloride 0.13%

Inactive Ingredients

water, cocamidopropyl betaine, PEG-7 glyceryl cocoate, propylene glycol, tetrasodium edta, phenoxyethanol, sodium benzoate, lactic acid


Structured Label Content

Uses

For hand sanitizing to decrease bacteria on the skin

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)

Stop use and ask a doctor

  • if irritation or redness develops
  • condition persists for more than 72 hours
Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

If contact occurs, rinse eyes thoroughly with water.

Section 51945-4 (51945-4)

For

sensitive

skin

0% Alcohol

aeris

guard

ACTISAN

Hand Sanitizer

Complies with EN-13727-Bactericidal test

For sensitive skin Leaves soft skin feel

Contains moisturizer and emollient Mild and skin compatible

Non-tacky

Active moisturizer

Fragrance free and pH balanced

ALCOHOL

FREE

NET CONTENTS

3.5 fl. oz. (103mL)

Purpose

Antiseptic

Warnings (WARNINGS)

For External use only

Directions
  • Apply enough product to cover hands
  • Rub together until dry without wiping
Other Information

Store at room temperature

Active Ingredients

Benzalkonium chloride 0.13%

Inactive Ingredients

water, cocamidopropyl betaine, PEG-7 glyceryl cocoate, propylene glycol, tetrasodium edta, phenoxyethanol, sodium benzoate, lactic acid


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)