SPL v1
SPL
SPL Set ID abb6da77-b973-fb9d-e053-2a95a90a8be9
Route
TOPICAL
Published
Effective Date 2020-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.197 g)
Inactive Ingredients
Phenoxyethanol Edetate Disodium Anhydrous Sodium Benzoate Water Citric Acid Monohydrate Glycerin Polysorbate 20 .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-27
Description

benzalkonium chloride

Medication Information

Warnings and Precautions

For external use only. Flammable. Keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

wet hands thoroughly with product and allow to dry without wiping

for children under 6, use only under adult supervision

not recommended for infants

Dosage and Administration

for external use only

Description

benzalkonium chloride

Section 50565-1

keep out of reach of the children

Section 51727-6

water, disodium EDTA, sodium benzoate, glycerin, polysorbate 20, tocopheryl acetate, phenoxyethanol, citric acid

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

benzalkonium chloride

Structured Label Content

Indications and Usage (34067-9)

wet hands thoroughly with product and allow to dry without wiping

for children under 6, use only under adult supervision

not recommended for infants

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

For external use only. Flammable. Keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

water, disodium EDTA, sodium benzoate, glycerin, polysorbate 20, tocopheryl acetate, phenoxyethanol, citric acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

benzalkonium chloride

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:22.599810 · Updated: 2026-03-14T22:57:52.290562