47993-323

47993-323
SPL v1
SPL
SPL Set ID 29df9759-f903-4439-91f5-7a8e189e317e
Route
TOPICAL
Published
Effective Date 2021-03-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.3 g)
Inactive Ingredients
Water Glycerin Microcrystalline Cellulose Trolamine Polyoxyl 40 Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-03-22
Description

Active ingredients Benzalkonium Chloride 0.3%

Medication Information

Warnings and Precautions

Warnings:

For external use only.Flammable.

Keep away from fire or 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,Glycerine,Cellulose,Triethanolamine,Ethoxylated hydrogenated castor oil,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 or 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,Glycerine,Cellulose,Triethanolamine,Ethoxylated hydrogenated castor oil,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: 2026-02-15T11:59:28.149922 · Updated: 2026-03-14T22:59:26.836242