SPL v3
SPL
SPL Set ID 60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b8
Route
TOPICAL
Published
Effective Date 2014-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Gentian Violet Cation (2 g)
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-14

Description

Gentian Violet 2%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Gentian Violet 2%

Warnings

For external use only

Directions

Clean the affected area. Apply a small amount using a cotton-tipped applicator one to three times daily. Do not bandage.

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 the product; do not apply to ulcerative lesions as this may result in tattooing of the skin.

Active Ingredient

Gentian Violet 2%

Other Information

Store at controlled room temperature. Will stain skin and clothing.

Inactive Ingredients

SD alcohol (10%), water

Principal Display Panel

Questions Or Suggestions?

1.855.763.8733 or visit us at www.thepodiatreecompany.com

Keep Out of Reach of Children.

In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Stop Use and Ask A Doctor Or Pharmacist

if skin irritation or sensitivity develops or increases or if the condition persists or gets worse.


Structured Label Content

Purpose

Antiseptic

Warnings

For external use only

Directions

Clean the affected area. Apply a small amount using a cotton-tipped applicator one to three times daily. Do not bandage.

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 the product; do not apply to ulcerative lesions as this may result in tattooing of the skin.

Active Ingredient

Gentian Violet 2%

Other Information

Store at controlled room temperature. Will stain skin and clothing.

Inactive Ingredients

SD alcohol (10%), water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Questions Or Suggestions? (Questions or Suggestions?)

1.855.763.8733 or visit us at www.thepodiatreecompany.com

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Stop Use and Ask A Doctor Or Pharmacist (Stop use and ask a doctor or pharmacist)

if skin irritation or sensitivity develops or increases or if the condition persists or gets worse.


Advanced Ingredient Data


Raw Label Data

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