15b12d2d-ea55-db0e-e063-6394a90a924a

SPL v1
SPL
SPL Set ID 15b12d2d-ea55-db0e-e063-6394a90a924a
Route
topical
Published
Effective Date 2024-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 g)
Inactive Ingredients
polysorbate 20 citric acid monohydrate limonene, (+)- linalool, (+/-)- peg-7 glyceryl cocoate water .alpha.-hexylcinnamaldehyde lime oil geraniol benzyl benzoate citral .beta.-citronellol, (r)- cocamidopropyl betaine phenoxyethanol glycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-05-01
Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only

Uses

To decrease bacteria on skin

Purpose

Antibacterial

Directions
  • Remove lid, open cap, thread wipe through slit and close lid
  • Gently remove wipe, clean skin thoroughly, and allow hands to dry
  • Do not flush, dispose in a waste basket, and close lid after use
  • Store at room temperature and protect from sun exposure
  • For children under 2 years old, ask a doctor before use
Other Information

Production date, expiration date, and lot number are printed on the package

Inactive Ingredients

Water, Phenoxyethanol, Peg 7 Glyceryl Cocoate, Polysorbate 20, Glycerin, Perfume (Lime Oil), Cocamidopropyl Betaine, Citric Acid, Limonene, Hexyl Cinnamal, Citral, Citronellol, Geraniol, Benzyl Benzoate, Linalool

Description

Benzalkonium Chloride 0.13%

Active Ingredient

Benzalkonium Chloride 0.13%

When Using This Product

When using this product, avoid contacting eyes. In cases of eye contact, rinse eyes thoroughly with water

Stop Use and Ask A Doctor

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours

Keep Out of Reach of Children

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center immediately

Package Label Principal Display Panel

Structured Label Content

Warnings

For external use only

Uses

To decrease bacteria on skin

Purpose

Antibacterial

Directions
  • Remove lid, open cap, thread wipe through slit and close lid
  • Gently remove wipe, clean skin thoroughly, and allow hands to dry
  • Do not flush, dispose in a waste basket, and close lid after use
  • Store at room temperature and protect from sun exposure
  • For children under 2 years old, ask a doctor before use
Other Information

Production date, expiration date, and lot number are printed on the package

Inactive Ingredients

Water, Phenoxyethanol, Peg 7 Glyceryl Cocoate, Polysorbate 20, Glycerin, Perfume (Lime Oil), Cocamidopropyl Betaine, Citric Acid, Limonene, Hexyl Cinnamal, Citral, Citronellol, Geraniol, Benzyl Benzoate, Linalool

Active Ingredient

Benzalkonium Chloride 0.13%

When Using This Product (When using this product)

When using this product, avoid contacting eyes. In cases of eye contact, rinse eyes thoroughly with water

Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center immediately

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:01.641234 · Updated: 2026-03-14T23:02:53.135799