47993-366

47993-366
SPL v2
SPL
SPL Set ID 6e50c5c7-64b2-4d5e-bf26-9b54f9240b1d
Route
TOPICAL
Published
Effective Date 2024-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.3 g)
Inactive Ingredients
Water Polyoxyl 40 Hydrogenated Castor Oil Hydroxyethyl Cellulose (5000 Mpa.s At 1%) Glycerin Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-15
Description

Active ingredients Benzalkonium Chloride 0.3%

Medication Information

Warnings and Precautions

Warnings:

For external use only.

Flammable. Keep away from fire and flame.

Indications and Usage

Uses：

For hand sanitizing to reduce bacteria on the skin.

Dosage and Administration

Directions:

Squeeze small amount in your palm and briskly rub hands together until dry.

Description

Active ingredients Benzalkonium Chloride 0.3%

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.

Section 50567-7

When using this product，do not use in or near the eyes.In case of contact，rinse eyes thoroughly with water.

Section 51727-6

Inactive Ingredients:

Water, Polyoxyl 40 Hydrogenated Castor Oil, Hydroxyethyl Cellulose (5000 Mpa.S At 1%), Glycerin, Phenoxyethanol, Fragrance.

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Active ingredients

Benzalkonium Chloride 0.3%

Structured Label Content

Indications and Usage (34067-9)

Uses：

For hand sanitizing to reduce bacteria on the skin.

Dosage and Administration (34068-7)

Directions:

Squeeze small amount in your palm and briskly rub hands together until dry.

Warnings and Precautions (34071-1)

Warnings:

For external use only.

Flammable. Keep away from fire and flame.

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.

Section 50567-7 (50567-7)

When using this product，do not use in or near the eyes.In case of contact，rinse eyes thoroughly with water.

Section 51727-6 (51727-6)

Inactive Ingredients:

Water, Polyoxyl 40 Hydrogenated Castor Oil, Hydroxyethyl Cellulose (5000 Mpa.S At 1%), Glycerin, Phenoxyethanol, Fragrance.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Active ingredients

Benzalkonium Chloride 0.3%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:25.705840 · Updated: 2026-03-14T23:03:29.554848