SPL v1
SPL
SPL Set ID f41d6294-a88a-4ee6-b0c1-b559b5723403
Route
TOPICAL
Published
Effective Date 2020-07-26
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 Sodium Chloride Decyl Glucoside Glycerin Anhydrous Citric Acid Edetate Sodium Methylchloroisothiazolinone/methylisothiazolinone Mixture

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-25

Description

Benzalkonium Chloride   0.13%


Medication Information

Description

Benzalkonium Chloride   0.13%

Uses

Effective in destroying harmful bacteria. Do not use on DivaCup.

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.
Active Ingredient

Benzalkonium Chloride   0.13%

Inactive Ingredients

Aqua/Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Decyl Glucoside, Glycerin, Citric acid, Tetrasodium EDTA, Methylchloroisothiazolinone and Methylisothiazolinone, CI 19140, CI 42090, Parfum.

Package Label Principal Display Panel


Structured Label Content

Uses

Effective in destroying harmful bacteria. Do not use on DivaCup.

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.
Active Ingredient (Active ingredient)

Benzalkonium Chloride   0.13%

Inactive Ingredients (Inactive ingredients)

Aqua/Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Decyl Glucoside, Glycerin, Citric acid, Tetrasodium EDTA, Methylchloroisothiazolinone and Methylisothiazolinone, CI 19140, CI 42090, Parfum.

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


Advanced Ingredient Data


Raw Label Data

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