423af3d9-6413-c097-e063-6294a90ae1a9

SPL v1
SPL
SPL Set ID 423af3d9-6413-c097-e063-6294a90ae1a9
Route
topical
Published
Effective Date 2025-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
water propylene glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-11-17

Purpose

Antiseptic / Antimicrobial

Description

Benzalkonium Chloride 0.13%


Medication Information

Uses

For hand washing to help reduce bacteria on skin that could cause disease.

Purpose

Antiseptic / Antimicrobial

Directions

Foam onto palm, massage into hands and under fingernails and air dry. Young children use with supervision.

Description

Benzalkonium Chloride 0.13%

Store

At room temperature not below 33°F.

Section 51945-4

Antibacterial Foam

Hand Sanitizer & Protectant

Protects Significantly Longer than Alcohol

Water-Based

Alcohol Free

Caution

FOR EXTERNAL USE ONLY Avoid contact with eyes. In case of contact, flush with water. Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, contact a physician.

Active Ingredient

Benzalkonium Chloride 0.13%

Other Ingredients

Purified Water, Propylene Glycol, Methyl Anthranilate, Trihydroxysilylpropyldimethylocatedecyl Ammonium Chloride.

Keep Out of Reach of Children

In case of accidental ingestion, get medical help or contact the Poison Control Center immediately.


Structured Label Content

Uses

For hand washing to help reduce bacteria on skin that could cause disease.

Purpose

Antiseptic / Antimicrobial

Directions

Foam onto palm, massage into hands and under fingernails and air dry. Young children use with supervision.

Store

At room temperature not below 33°F.

Section 51945-4 (51945-4)

Antibacterial Foam

Hand Sanitizer & Protectant

Protects Significantly Longer than Alcohol

Water-Based

Alcohol Free

Caution (CAUTION)

FOR EXTERNAL USE ONLY Avoid contact with eyes. In case of contact, flush with water. Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, contact a physician.

Active Ingredient

Benzalkonium Chloride 0.13%

Other Ingredients

Purified Water, Propylene Glycol, Methyl Anthranilate, Trihydroxysilylpropyldimethylocatedecyl Ammonium Chloride.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

In case of accidental ingestion, get medical help or contact the Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)