SPL v1
SPL
SPL Set ID 3e002cee-6102-1db4-e063-6394a90ac7a1
Route
TOPICAL
Published
Effective Date 2025-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Peg-6 Cocamide Methylisothiazolinone Laurtrimonium Chloride Aloe Vera Leaf Juice Cocamidopropyl Betaine Water Iodopropynyl Butylcarbamate D&c Red No. 33 Cocamidopropyl Propylene Glycol-dimonium Chloride Phosphate Fd&c Yellow No. 5 .alpha.-tocopherol Acetate

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-04

Description

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Uses

Uses handwashing to help decrease bacteria on the skin

Section 51945-4

Warnings

Warnings

For external use only

Directions

Directions

  • wet hands
  • apply product and thoroughly cover hands with lather for 30 seconds
  • rinse well and dry hands completely
Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients

Inactive Ingredients: Water, Laurtrimonium Chloride, Cocamidopropyl Betaine, PEG-6 Cocamide, Cocamidopropyl PG-Dimonium Chloride Phosphate, Fragrance, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Methylisothiazolinone, Iodopropynyl Butylcarbamate, Yellow # 5, Red # 33

When Using This Product

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water

Stop Use and Ask A Doctor If

Stop use and ask a doctor if irritation or redness develops and lasts 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 right away


Structured Label Content

Uses

Uses handwashing to help decrease bacteria on the skin

Section 51945-4 (51945-4)

Purpose

Antimicrobial

Warnings

Warnings

For external use only

Directions

Directions

  • wet hands
  • apply product and thoroughly cover hands with lather for 30 seconds
  • rinse well and dry hands completely
Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients

Inactive Ingredients: Water, Laurtrimonium Chloride, Cocamidopropyl Betaine, PEG-6 Cocamide, Cocamidopropyl PG-Dimonium Chloride Phosphate, Fragrance, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Methylisothiazolinone, Iodopropynyl Butylcarbamate, Yellow # 5, Red # 33

When Using This Product (When using this product)

When using this product do not use in or near the eyes. In case of contact, rinse 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 or redness develops and lasts 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 right away


Advanced Ingredient Data


Raw Label Data

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