SPL v4
SPL
SPL Set ID b326d984-287a-7f7d-e053-2995a90aaf13
Route
TOPICAL
Published
Effective Date 2020-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1 mg)
Inactive Ingredients
Lactic Acid Water Glycerin Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-11-13
Description

Benzalkonium Chloride 0.1%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use
Dosage and Administration
  • Pump a small amount of gel into palm of hand
  • Rub thoroughly over all surfaces of both hands
  • Rub hands together briskly until dry.
Description

Benzalkonium Chloride 0.1%

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

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Section 50567-7

When using this product, avoid contact with eyes. In case of eye contact, flush eyes with water.

Section 51727-6

Water, carbomer, glycerin, lactic acid.

Section 51945-4

1 Gal 74146-239-01

Section 55105-1

Antimicrobial

Section 55106-9

Benzalkonium Chloride 0.1%

Structured Label Content

Indications and Usage (34067-9)
  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use
Dosage and Administration (34068-7)
  • Pump a small amount of gel into palm of hand
  • Rub thoroughly over all surfaces of both hands
  • Rub hands together briskly until dry.
Warnings and Precautions (34071-1)

For external use only

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)

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product, avoid contact with eyes. In case of eye contact, flush eyes with water.

Section 51727-6 (51727-6)

Water, carbomer, glycerin, lactic acid.

Section 51945-4 (51945-4)

1 Gal 74146-239-01

Section 55105-1 (55105-1)

Antimicrobial

Section 55106-9 (55106-9)

Benzalkonium Chloride 0.1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:08.639827 · Updated: 2026-03-14T22:59:00.992624