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.
Active Ingredient

​Active Ingredient

​Benzalkonium Chloride 0.13%

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


Structured Label Content

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.
Active Ingredient (55106-9)

​Active Ingredient

​Benzalkonium Chloride 0.13%

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.
Labels (labels)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)