SPL v2
SPL
SPL Set ID 3dfbe75e-9906-18d7-e063-6294a90ac32e
Route
TOPICAL
Published
Effective Date 2025-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Edetate Disodium Fd&c Yellow No. 5 Anhydrous Citric Acid Peg-120 Methyl Glucose Dioleate Water Coco Monoethanolamide Cetrimonium Chloride Sodium Chloride Lauramine Oxide Sorbitol Sodium Lauriminodipropionate Methylchloroisothiazolinone/methylisothiazolinone Mixture D&c Red No. 33

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, Cetrimonium Chloride, Sodium Chloride, Lauramine Oxide, Sorbitol, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Sodium Lauriminodipropionate, Fragrance, Citric Acid, Disodium EDTA, Methylisothiazolinone, Methylchloroisothiazolinone, 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

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, Cetrimonium Chloride, Sodium Chloride, Lauramine Oxide, Sorbitol, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Sodium Lauriminodipropionate, Fragrance, Citric Acid, Disodium EDTA, Methylisothiazolinone, Methylchloroisothiazolinone, 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 (Stop use and ask a doctor)

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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