SPL v1
SPL
SPL Set ID 24a871b4-1079-df8c-e063-6394a90a5677
Route
TOPICAL
Published
Effective Date 2024-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 g)
Inactive Ingredients
Water Olive Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-15

Description

Salicylic Acid

Purpose

Anti-fungal


Medication Information

Purpose

Anti-fungal

Description

Salicylic Acid

Uses

Uses for relief and treatment of pain,soreness, and inflammation from nail fungus.

Symptoms: ■ discolored nails ■ brittle nails ■ distorted nails

Warnings

For external use only, Some individuals may be sensitive to essential oils.

Begin with a small drop to determine if product causes any irritation. Discontinue use if any irritation occurs.

Stop use and consult a doctor if condition worsens, Not for use on children under the age of 2 without physician direction.

Do Not Use

on damaged or broken skik

Active Ingredients

Salicylic Acid

Inactive Ingredients

Water

Dosage & Administration

shake well before use.Wash and thoroughly dry the affectedarea. Apply 1-2 drops and gently rubinto affected area three times per day.

Principal Display Panel

Stop Use and Ask A Doctor If

rash occur

Keep Out of Reach of Children.

If swallwed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

Uses for relief and treatment of pain,soreness, and inflammation from nail fungus.

Symptoms: ■ discolored nails ■ brittle nails ■ distorted nails

Purpose (PURPOSE)

Anti-fungal

Warnings

For external use only, Some individuals may be sensitive to essential oils.

Begin with a small drop to determine if product causes any irritation. Discontinue use if any irritation occurs.

Stop use and consult a doctor if condition worsens, Not for use on children under the age of 2 without physician direction.

Do Not Use (Do not use)

on damaged or broken skik

Active Ingredients (Active ingredients)

Salicylic Acid

Inactive Ingredients (inactive ingredients)

Water

Dosage & Administration (DOSAGE & ADMINISTRATION)

shake well before use.Wash and thoroughly dry the affectedarea. Apply 1-2 drops and gently rubinto affected area three times per day.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occur

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

If swallwed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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