a33c7228-12b1-470e-b482-38f2cabe76ff

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

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.
Uses

Effective in destroying harmful bacteria, while moisturizing hands.

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.
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

Description

Benzalkonium Chloride   0.10%

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

Active Ingredient

Benzalkonium Chloride   0.10%

Package Label Principal Display Panel

Structured Label Content

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.
Uses

Effective in destroying harmful bacteria, while moisturizing hands.

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.
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

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)

Active Ingredient (Active ingredient)

Benzalkonium Chloride   0.10%

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

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