50563-343_g1abcw07

50563-343_g1abcw07
SPL v1
SPL
SPL Set ID 65df72d9-59ac-410a-b79c-bc5a5730e3ce
Route
TOPICAL
Published
Effective Date 2020-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (4.5 mg)
Inactive Ingredients
Glycerin Ethylhexylglycerin Phenoxyethanol Propylene Glycol Water Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-23
Description

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.1%

Use

■ To decrease bacteria on hands

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Section 50567-7

When using this product, avoid contact with eyes. In case of contact with eyes, rinse eyes thoroughly with water

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 51945-4

Warnings

For external use only

Directions

For adults and children two years and over

Peel over reusable label and remove a wipe from the packet.

Wet hands thoroughly and air dry. 

Place used wipes in to waste basket.  Do not flush.

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Rubus Idaeus (Raspberry) Fruit Extract, Water

Structured Label Content

Use

■ To decrease bacteria on hands

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Section 50567-7 (50567-7)

When using this product, avoid contact with eyes. In case of contact with eyes, rinse eyes thoroughly with water

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warnings (WARNINGS)

For external use only

Directions

For adults and children two years and over

Peel over reusable label and remove a wipe from the packet.

Wet hands thoroughly and air dry. 

Place used wipes in to waste basket.  Do not flush.

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Extract, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Rubus Idaeus (Raspberry) Fruit Extract, Water

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:57.593221 · Updated: 2026-03-14T22:58:45.636917