SPL v1
SPL
SPL Set ID 2038b576-8b80-4ba8-a552-e5372f9f2a0d
Route
TOPICAL
Published
Effective Date 2014-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Lauramine Oxide Cocamidopropyl Betaine Disodium Cocoamphodipropionate Glycerin Methylchloroisothiazolinone Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-02-03
Description

Active Ingredient Benzalkonium Chloride 0.13%

Medication Information

Warnings and Precautions

Warnings

  • For external use only
  • When using this product avoid contact with eyes. In case of eye contact flush eyes with water. Do not ingest.
  • Stop use and ask a doctor if irritation or redness develops and conditions persist.
Indications and Usage

Directions

  • Apply small amount of product to wet hands
  • Work into lather and rinse thoroughly
  • Dry hands
Dosage and Administration

Uses

  • For Hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use
Description

Active Ingredient Benzalkonium Chloride 0.13%

Section 50565-1

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

Section 51727-6

Inactive Ingredients

  • Water
  • Lauramine oxide
  • cocamidopropyl betaine
  • disodium cocoamphodipropionate
  • glycerin
  • methylchloroisothiazolinone
  • sodium chloride
Section 51945-4

Section 55105-1

Purpsoe

Antimicrobial

Section 55106-9

Active Ingredient

Benzalkonium Chloride 0.13%

Structured Label Content

Indications and Usage (34067-9)

Directions

  • Apply small amount of product to wet hands
  • Work into lather and rinse thoroughly
  • Dry hands
Dosage and Administration (34068-7)

Uses

  • For Hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use
Warnings and Precautions (34071-1)

Warnings

  • For external use only
  • When using this product avoid contact with eyes. In case of eye contact flush eyes with water. Do not ingest.
  • Stop use and ask a doctor if irritation or redness develops and conditions persist.
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 51727-6 (51727-6)

Inactive Ingredients

  • Water
  • Lauramine oxide
  • cocamidopropyl betaine
  • disodium cocoamphodipropionate
  • glycerin
  • methylchloroisothiazolinone
  • sodium chloride
Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpsoe

Antimicrobial

Section 55106-9 (55106-9)

Active Ingredient

Benzalkonium Chloride 0.13%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:44.899278 · Updated: 2026-03-14T22:53:40.468762