SPL v1
SPL
SPL Set ID a33c7228-12b1-470e-b482-38f2cabe76ff
Route
TOPICAL
Published
Effective Date 2020-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1 g)
Inactive Ingredients
Water Glycerin Cetyl Alcohol Medium-chain Triglycerides Edetate Disodium Glyceryl Stearate/peg-100 Stearate Olive Oil Allantoin Lavender Oil Bentonite Dimethicone Aloe Vera Leaf .alpha.-tocopherol Acetate Chamomile Amino Acids, Silk Panthenol Butylated Hydroxytoluene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-01
Description

Benzalkonium Chloride   0.10%

Medication Information

Description

Benzalkonium Chloride   0.10%

Uses

Effective in destroying harmful bacteria, while moisturizing hands.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 55105-1

Warnings
  • For external use only.
  • 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 irritation or rash appears and lasts.
Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Active Ingredient

Benzalkonium Chloride   0.10%

Inactive Ingredients

Aqua/Water, Glyceryl Stearate (and) PEG-100 Stearate, Olea Europaea (Olive) Fruit Oil, Caprylic/Capric Triglycerides, Glycerin, Cetyl alcohol, Olea Europaea (Olive) Oil, Sodium Polyacrylate (and) C13-14 Isoparaffin (and) Laureth-7, Allantoin, Disodium EDTA, Dimethicone, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Butylated Hydrxytoluene, Lavandula Angustifolia, Matricaria Recutita (Chamomile) Extract, Silk Amino Acids, Panthenol

Package Label Principal Display Panel

Structured Label Content

Uses

Effective in destroying harmful bacteria, while moisturizing hands.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 55105-1 (55105-1)

Warnings
  • For external use only.
  • 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 irritation or rash appears and lasts.
Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Active Ingredient (Active ingredient)

Benzalkonium Chloride   0.10%

Inactive Ingredients (Inactive ingredients)

Aqua/Water, Glyceryl Stearate (and) PEG-100 Stearate, Olea Europaea (Olive) Fruit Oil, Caprylic/Capric Triglycerides, Glycerin, Cetyl alcohol, Olea Europaea (Olive) Oil, Sodium Polyacrylate (and) C13-14 Isoparaffin (and) Laureth-7, Allantoin, Disodium EDTA, Dimethicone, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Butylated Hydrxytoluene, Lavandula Angustifolia, Matricaria Recutita (Chamomile) Extract, Silk Amino Acids, Panthenol

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:26.299291 · Updated: 2026-03-14T22:56:35.991862