Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID cb062055-51a5-30ab-e053-2995a90a534a
Route
TOPICAL
Published
Effective Date 2021-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (130 mg)
Inactive Ingredients
Glycerin Cetrimonium Chloride Citric Acid Monohydrate Methylisothiazolinone Basic Yellow 5 Lauramidopropylamine Oxide Sodium Chloride Citrus Nobilis Camellia Sinensis Flower Coco Monoethanolamide Peg-120 Methyl Glucose Dioleate Zingiber Officinale Whole Fragrance Fresh Citrus Floral Orc1501495 Sodium Sulfate Direct Yellow 6 Water Edetate Sodium Methylchloroisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-08-26
Description

Benzalkonium Chloride (0.13%)

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride (0.13%)

Uses

Helps eliminate bacteria on hands.

Pdp03

Warnings

For external use only.

Directions
  • Apply onto wet hands.
  • Lather and rinse thoroughly..
Active Ingredient

Benzalkonium Chloride (0.13%)

Other Information

Store at Room Temperature

Inactive Ingredients

Water (Aqua), Cetrimonium Chloride, Lauramidopropylamine Oxide, Glycerin, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Citrus Nobilis (Mandarin Orange) Peel Extract, Camellia Sinensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (Cl 19140), Yellow 6 (Cl 15985).

When Using This Product
  • Avoid contact with eyes. In case of contact, rinse thoroughly with water.
Stop Use and Ask A Doctor If
  • irritation or redness develops and lasts.
Keep Out of Reach of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Uses

Helps eliminate bacteria on hands.

Pdp03 (PDP03)

Purpose

Antibacterial

Warnings

For external use only.

Directions
  • Apply onto wet hands.
  • Lather and rinse thoroughly..
Active Ingredient

Benzalkonium Chloride (0.13%)

Other Information

Store at Room Temperature

Inactive Ingredients

Water (Aqua), Cetrimonium Chloride, Lauramidopropylamine Oxide, Glycerin, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Citrus Nobilis (Mandarin Orange) Peel Extract, Camellia Sinensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (Cl 19140), Yellow 6 (Cl 15985).

When Using This Product (When using this Product)
  • Avoid contact with eyes. In case of contact, rinse thoroughly with water.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation or redness develops and lasts.
Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:40.675133 · Updated: 2026-03-14T22:59:46.973860