SPL v3
SPL
SPL Set ID d6d7c68f-a94b-4a66-935d-e092a4171ae3
Route
TOPICAL
Published
Effective Date 2020-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Sodium Laureth Sulfate Cocamidopropyl Betaine Glycol Distearate Methylchloroisothiazolinone Methylisothiazolinone Sodium Chloride Citric Acid Monohydrate Aloe Vera Leaf .alpha.-tocopherol Acetate Chamomile

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-03

Description

Benzalkonium chloride 0.13%

Purpose

Antiseptic skin cleanser


Medication Information

Purpose

Antiseptic skin cleanser

Description

Benzalkonium chloride 0.13%

Use
  • Antiseptic (skin) cleanser
  • Medicated (skin) cleanser
  • Antibacterial (skin) cleanser
  • Eliminates harmful bacteria/germs
  • Effective in destroying (harmful) bacteria to provide antiseptic cleansing
  • For personal hand hygiene to help prevent the spread of bacteria
Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

In case of contact with eyes, rinse eyes thoroughly with water.

Directions

Lather in hands with water for at least 30 seconds. Rinse well.

Active Ingredient

Benzalkonium chloride 0.13%

Inactive Ingredients

Aqua/Eau/Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glycol Distearate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Matricaria recutita (Chamomile) Extract, Parfum, Methylchloroisothiazolinone (and) Methylisothiazolinone, Citric Acid.

Package Label Principal Display Panel


Structured Label Content

Use
  • Antiseptic (skin) cleanser
  • Medicated (skin) cleanser
  • Antibacterial (skin) cleanser
  • Eliminates harmful bacteria/germs
  • Effective in destroying (harmful) bacteria to provide antiseptic cleansing
  • For personal hand hygiene to help prevent the spread of bacteria
Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antiseptic skin cleanser

Warnings

For external use only.

In case of contact with eyes, rinse eyes thoroughly with water.

Directions

Lather in hands with water for at least 30 seconds. Rinse well.

Active Ingredient

Benzalkonium chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Aqua/Eau/Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glycol Distearate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Matricaria recutita (Chamomile) Extract, Parfum, Methylchloroisothiazolinone (and) Methylisothiazolinone, Citric Acid.

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


Advanced Ingredient Data


Raw Label Data

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