0.13ben Fanjia

0.13ben Fanjia
SPL v5
SPL
SPL Set ID b32f773e-f8fb-3739-e053-2a95a90a7b45
Route
TOPICAL
Published
Effective Date 2020-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Polysorbate 20 Phenoxyethanol Propylene Glycol Isopropyl Alcohol .alpha.-tocopherol Acetate, D- Water Fagraea Berteroana Flower Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-11-03
Description

benzalkonium chloride 0.13%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

benzalkonium chloride 0.13%

Uses

Suitable for skin cleaning and sterilization

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if irritation or redness develop.

Section 50567-7

When using this product, avoid contact with eyes.In case of contact with eyes, rinse with water to remove.



Warnings

For external use only.

Flammable,keep away from fire or flame

Directions
  • Wet hands thoroughly with product and allow to dry without wiping
Do Not Use

  • on open skin wounds
Other Information
  • Do not store above 110F
  • May discolor some fabrics
Active Ingredient(s)

benzalkonium chloride 0.13%

Inactive Ingredients

Aqua,Isopropyl alcohol, Propylene glycol, Tocopherol acetate, polysorbote 20, phenoxyethanol, Perfume

Package Label Principal Display Panel

160PCS NDC 80991-003-04

Structured Label Content

Uses

Suitable for skin cleaning and sterilization

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 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develop.

Section 50567-7 (50567-7)

When using this product, avoid contact with eyes.In case of contact with eyes, rinse with water to remove.



Purpose

Antimicrobial

Warnings

For external use only.

Flammable,keep away from fire or flame

Directions
  • Wet hands thoroughly with product and allow to dry without wiping
Do Not Use (Do not use)

  • on open skin wounds
Other Information (Other information)
  • Do not store above 110F
  • May discolor some fabrics
Active Ingredient(s)

benzalkonium chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Aqua,Isopropyl alcohol, Propylene glycol, Tocopherol acetate, polysorbote 20, phenoxyethanol, Perfume

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

160PCS NDC 80991-003-04

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:15.355393 · Updated: 2026-03-14T22:59:10.507926