SPL v2
SPL
SPL Set ID ae2420f1-f906-0b39-e053-2a95a90a2089
Route
TOPICAL
Published
Effective Date 2020-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 mg)
Inactive Ingredients
Water Phenoxyethanol Glycerin Ethylhexylglycerin Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-30
Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses

To decrease bacteria on the skin that could cause disease

Warnings

For external use only.

Directions
  • Take wipe from pouch and rub thoroughly over all surfaces of both hands.
  • Rub hands together briskly to dry.
  • Dispose of wipe.
Active Ingredient

Benzalkonium Chloride 0.13%

Other Information
  • Keep containers tightly closed in a dry, cool and well-ventilated place.
Inactive Ingredients

Ethylhexylglycerin ,Glycerin,Phenoxyethanol, Propylene Glycol,Purified Water

When Using This Product

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

Stop Use and Ask A Doctor If

Stop use and ask a doctor if irritation and redness develop and persist.

Keep Out of Reach of Children

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

Package Label/principal Display Panel

NDC 79650--013-40; 170 mL

Structured Label Content

Uses

To decrease bacteria on the skin that could cause disease

Purpose

Antibacterial

Warnings

For external use only.

Directions
  • Take wipe from pouch and rub thoroughly over all surfaces of both hands.
  • Rub hands together briskly to dry.
  • Dispose of wipe.
Active Ingredient

Benzalkonium Chloride 0.13%

Other Information
  • Keep containers tightly closed in a dry, cool and well-ventilated place.
Inactive Ingredients

Ethylhexylglycerin ,Glycerin,Phenoxyethanol, Propylene Glycol,Purified Water

When Using This Product (When using this product)

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

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

Stop use and ask a doctor if irritation and redness develop and persist.

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 right away.

Package Label/principal Display Panel (Package Label/Principal Display Panel)

NDC 79650--013-40; 170 mL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:36.162473 · Updated: 2026-03-14T22:58:14.813588