f41d6294-a88a-4ee6-b0c1-b559b5723403

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

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. Do not use on DivaCup.

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.

Description

Benzalkonium Chloride   0.13%

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   0.13%

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. Do not use on DivaCup.

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.

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   0.13%

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: 2026-02-15T11:58:23.691623 · Updated: 2026-03-14T22:57:55.937889