Antibacterial Foaming Skin Cleanser

Antibacterial Foaming Skin Cleanser
SPL v10
SPL
SPL Set ID e5cb1df5-1e13-4a0b-939e-071c577bcf15
Route
TOPICAL
Published
Effective Date 2025-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 mg)
Inactive Ingredients
Fd&c Yellow No. 5 Geraniol 2-tert-butylcyclohexyloxybutanol Dihydromyrcenol Tetrasodium Glutamate Diacetate Anhydrous Citric Acid Allyl Heptanoate Water Glycerin Magnesium Nitrate Alcohol Aloe Vera Leaf Methylchloroisothiazolinone Methylisothiazolinone Fd&c Red No. 40 Cocamidopropylamine Oxide Linalool, (+/-)- 2-tert-butylcyclohexyl Acetate Citral N-alkyl Dimethyl Benzyl Ammonium Chloride (c12-c18) Hydrogen Peroxide Limonene, (+)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-07-19
Description

​Active Ingredient ​ ​Benzalkonium Chloride 0.13%

Medication Information

Warnings and Precautions

Warnings

  • For external use only.
  • Avoid contact with eyes.
  • If contact occurs, rinse thoroughly with water.
  • Discontinue use is irritation or redness develops.
  • If irritation persists for more than 72 hours, consult a physician.
  • KEEP OUT OF REACH OF CHILDREN.
  • If swallowed, get medical help or contact a Poison Control Center right away.
Indications and Usage

Uses

  • ​​Antibacterial skin cleanser.
  • Use in a variety of public facilities including daycare centers, hospitals, nursing homes, physicians offices.
Dosage and Administration

Directions

  • ​Read the entire label before using this product.
  • ​Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands.
  • Rinse with clean water.
Description

​Active Ingredient ​ ​Benzalkonium Chloride 0.13%

Labels

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 51727-6

Inactive Ingredients

​Water, Potasium Cocoate, Propylene Glycol, Glycerin, Tetrasodium EDTA, Fragrance, Bronopol, Sodium Citrate, Magnesium Nitrate, Sodium Hydroxyacetate, Ethanol, Aloe Barbadensis Leaf Juice, Trisodium Nitriloacetate, FD&C Yellow #5, Sodium Hydroxide, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C Red #40.

Section 55105-1

Purpose

Antibacterial

Section 55106-9

​Active Ingredient

​ ​Benzalkonium Chloride 0.13%

Structured Label Content

Labels (labels)

Indications and Usage (34067-9)

Uses

  • ​​Antibacterial skin cleanser.
  • Use in a variety of public facilities including daycare centers, hospitals, nursing homes, physicians offices.
Dosage and Administration (34068-7)

Directions

  • ​Read the entire label before using this product.
  • ​Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands.
  • Rinse with clean water.
Warnings and Precautions (34071-1)

Warnings

  • For external use only.
  • Avoid contact with eyes.
  • If contact occurs, rinse thoroughly with water.
  • Discontinue use is irritation or redness develops.
  • If irritation persists for more than 72 hours, consult a physician.
  • 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 CHILDREN

Section 51727-6 (51727-6)

Inactive Ingredients

​Water, Potasium Cocoate, Propylene Glycol, Glycerin, Tetrasodium EDTA, Fragrance, Bronopol, Sodium Citrate, Magnesium Nitrate, Sodium Hydroxyacetate, Ethanol, Aloe Barbadensis Leaf Juice, Trisodium Nitriloacetate, FD&C Yellow #5, Sodium Hydroxide, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C Red #40.

Section 55105-1 (55105-1)

Purpose

Antibacterial

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: 2026-02-15T12:06:14.331235 · Updated: 2026-03-14T23:13:55.868201