87001-004

87001-004
SPL v1
SPL
SPL Set ID 3c273544-4562-8f37-e063-6394a90ab4d3
Route
TOPICAL
Published
Effective Date 2025-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-12

Description

Benzalkonium Chloride 0.3%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.3%

Uses

For hand sanitizing to reduce bacteria on the skin.

Warnings

For external use only.

Flammable. Keep away from fire and flame.

Directions

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

87001 004 01

87001 004 02

Discontinue Use

if irritation or redness develops.

Active Ingredient

Benzalkonium Chloride 0.3%

Inactive Ingredients

WATER, POLYOXYL 40 HYDROGENATED CASTOR OIL, HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%), GLYCERIN, PHENOXYETHANOL, FRAGRANCE.

When Using This Product,

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

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For hand sanitizing to reduce bacteria on the skin.

Purpose

Antiseptic

Warnings

For external use only.

Flammable. Keep away from fire and flame.

Directions

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

87001 004 01 (87001-004-01)

87001 004 02 (87001-004-02)

Discontinue Use (Discontinue use)

if irritation or redness develops.

Active Ingredient

Benzalkonium Chloride 0.3%

Inactive Ingredients (Inactive ingredients)

WATER, POLYOXYL 40 HYDROGENATED CASTOR OIL, HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%), GLYCERIN, PHENOXYETHANOL, FRAGRANCE.

When Using This Product, (When using this product,)

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

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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