el valle merthiolate (benz chloride 0.13%)(da)

el valle merthiolate (benz chloride 0.13%)(da)
SPL v5
SPL
SPL Set ID fd7b28ca-9f71-0ff6-e053-6394a90a4822
Route
topical
Published
Effective Date 2023-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
fd&c red no. 40 alcohol water

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2023-05-31 Until 2027-10-01

Description

Drug facts


Medication Information

Warnings

FOR EXTERNAL USE ONLY.

Uses

First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Directions
  • clean the affected area
  • apply a small amount directly to the affected area 1 to 3 times a day
  • may cover area with a sterile bandage
Other Information
  • do not use if clear seal over cap is missing or broken
Inactive Ingredients

alcohol, FD&C red #40, water

Description

Drug facts

Section 55105-1
Active ingredient Purpose

Benzalkonium chloride 0.13%.............

First aid antiseptic

Do Not Use
  • longer than 1 week, unless directed by a doctor
  • in the eyes
  • over large areas of the body
Drug Facts

Drug facts

Prinicpal Display Panel

Keep Out of Reach of Children.

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

Stop Use and Consult A Doctor If
  • conditions persist or gets worse
Ask A Doctor Before Use If You Have
  • a deep or puncture wounds
  • serious burns
  • animal bites

Structured Label Content

Warnings

FOR EXTERNAL USE ONLY.

Uses

First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Directions
  • clean the affected area
  • apply a small amount directly to the affected area 1 to 3 times a day
  • may cover area with a sterile bandage
Other Information (Other information)
  • do not use if clear seal over cap is missing or broken
Inactive Ingredients (Inactive ingredients)

alcohol, FD&C red #40, water

Section 55105-1 (55105-1)
Active ingredient Purpose

Benzalkonium chloride 0.13%.............

First aid antiseptic

Do Not Use (Do not use)
  • longer than 1 week, unless directed by a doctor
  • in the eyes
  • over large areas of the body
Drug Facts

Drug facts

Prinicpal Display Panel

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)
  • conditions persist or gets worse
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a deep or puncture wounds
  • serious burns
  • animal bites

Advanced Ingredient Data


Raw Label Data

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