bfbe6385-2319-9b3e-e053-2a95a90abf9f

SPL v2
SPL
SPL Set ID bfbe6385-2319-9b3e-e053-2a95a90abf9f
Route
topical
Published
Effective Date 2021-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 g)
Inactive Ingredients
polyaminopropyl biguanide water alcohol cetylpyridinium chloride

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2021-04-12
Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings and Precautions

For external use only.

Active Ingredient

Benzalkonium Chloride 0.13%

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Directions

Place enough product on hands to cover all surfaces.Rub hands together until dry.

Other Information

Store in a cool dry place, away from direct sunlight and heat.

Description

Benzalkonium Chloride 0.13%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

Section 50566-9

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

Section 50567-7

When using this product keep out of eyes,ears, and mouth. ln case of contact with eyes,rinse eyes thoroughly with water.

Section 50570-1

Do not use on open skin wounds or children under 2 months of age.

Section 51727-6

water (aqua), polyaminopropyl biguanide, cetylpyridinium chloride, alcohol

Section 51945-4

Section 55105-1

Antiseptic

Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

Benzalkonium Chloride 0.13%

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Directions

Place enough product on hands to cover all surfaces.Rub hands together until dry.

Other Information (Other information)

Store in a cool dry place, away from direct sunlight and heat.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product keep out of eyes,ears, and mouth. ln case of contact with eyes,rinse eyes thoroughly with water.

Section 50570-1 (50570-1)

Do not use on open skin wounds or children under 2 months of age.

Section 51727-6 (51727-6)

water (aqua), polyaminopropyl biguanide, cetylpyridinium chloride, alcohol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:31.413148 · Updated: 2026-03-14T22:59:31.191887