60c88eb7-22fe-4881-e053-2a91aa0a70ce

SPL v3
SPL
SPL Set ID 60c88eb7-22fe-4881-e053-2a91aa0a70ce
Route
topical
Published
Effective Date 2017-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
phenol (1.5 g)
Inactive Ingredients
acetone resorcinol alcohol water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-01-03

Purpose

First Aid Antiseptic

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses
  • First aid antiseptic to help protect against skin infection in minor cuts, scrapes or burns
Purpose

First Aid Antiseptic

Directions
  • clean the affected area
  • apply a small amount on the area one to three times daily
Other Information

Store at controlled room temperature

Inactive Ingredients

Acetone, resorcinol, SD alcohol (13%), water

Description

Drug Facts

Principal Display Panel

Section 42229-5

Drug Facts

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 50566-9

Stop use and ask a doctor or pharmacist if skin irritation or sensitivity develops or increases or if the condition persists or gets worse.

Do Not Use
  • in eyes
  • with bandages
  • on large areas of the body
  • longer than one week unless directed by a doctor
  • stop use and consult a doctor if condition persists
  • in case of deep puncture wounds, animal bites, or serious burns, consult a doctor
  • if known to be sensitive to any ingredients in this product
Active Ingredient

Phenol 1.5%

When Using This Product
  • Check skin for sensitivity to phenol prior to application
  • Use caution when applying as this product will stain skin and clothing
Questions Or Suggestions?

1.855.763.8733 or visit us at www.thepodiatreecompany.com. Our commitment to you is 100% satisfaction. If you are not

completely satisfied, please contact us directly for a full refund.


Structured Label Content

Warnings

For external use only

Uses
  • First aid antiseptic to help protect against skin infection in minor cuts, scrapes or burns
Purpose

First Aid Antiseptic

Directions
  • clean the affected area
  • apply a small amount on the area one to three times daily
Other Information

Store at controlled room temperature

Inactive Ingredients

Acetone, resorcinol, SD alcohol (13%), water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Section 50566-9 (50566-9)

Stop use and ask a doctor or pharmacist if skin irritation or sensitivity develops or increases or if the condition persists or gets worse.

Do Not Use (Do not use)
  • in eyes
  • with bandages
  • on large areas of the body
  • longer than one week unless directed by a doctor
  • stop use and consult a doctor if condition persists
  • in case of deep puncture wounds, animal bites, or serious burns, consult a doctor
  • if known to be sensitive to any ingredients in this product
Active Ingredient

Phenol 1.5%

When Using This Product (When using this product)
  • Check skin for sensitivity to phenol prior to application
  • Use caution when applying as this product will stain skin and clothing
Questions Or Suggestions? (Questions or Suggestions?)

1.855.763.8733 or visit us at www.thepodiatreecompany.com. Our commitment to you is 100% satisfaction. If you are not

completely satisfied, please contact us directly for a full refund.


Advanced Ingredient Data


Raw Label Data

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