2c074675-8646-4378-9ee0-26716590bc17

SPL v3
SPL
SPL Set ID 2c074675-8646-4378-9ee0-26716590bc17
Route
topical
Published
Effective Date 2020-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 g)
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 2020-06-12

Purpose

Antiseptic skin cleanser

Description

Benzalkonium chloride 0.13%


Medication Information

Warnings

For external use only. In case of contact with eyes, rinse eyes thoroughly with water.

Uses
  • 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.
Purpose

Antiseptic skin cleanser

Directions

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

Inactive Ingredients

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

Description

Benzalkonium chloride 0.13%

Section 50565-1

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

Active Ingredient

Benzalkonium chloride 0.13%

Package Label Principal Display Panel


Structured Label Content

Warnings

For external use only. In case of contact with eyes, rinse eyes thoroughly with water.

Uses
  • 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.
Purpose

Antiseptic skin cleanser

Directions

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

Inactive Ingredients (Inactive ingredients)

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

Section 50565-1 (50565-1)

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

Active Ingredient

Benzalkonium chloride 0.13%

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


Advanced Ingredient Data


Raw Label Data

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