84844-013

84844-013
SPL v1
SPL
SPL Set ID 264b07c0-3319-82d7-e063-6394a90a24ff
Route
TOPICAL
Published
Effective Date 2024-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 g)
Inactive Ingredients
Water Glycerin Polyethylene Glycol, Unspecified Borneol Podofilox

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-07

Description

Salicylic acid 5%

Purpose

Wart remover


Medication Information

Purpose

Wart remover

Description

Salicylic acid 5%

Use

·for the removal of common and plantar warts

·the common wart is easily recognized by the rough “cauliflower-like” appearance on the surface.

·the plantar wart is recognized by its location only on the bottom of the foot, its tenderness and interruption of the footprint pattern

Stop Use

and ask a doctor if

discomfort persists.

Warnings

For external use only. Flammable.

Keep away from fire and flame.

Ask Doctor

discomfort persists.

Directions

·wash affected area

·may soak wart in warm water for 5 minutes

·dry area thoroughly

·by squeezing tube gently, apply one drop at a time to sufficiently cover each wart

·let dry

·repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks

Do Not Use

·on irritated skin or on any area that is infected or reddened

·on moles, birthmarks, warts with hair growing from them, genital warts or warts on the face or mucous membranes.

·if you have diabetes or poor blood circulation.

When Using

·avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes.

·avoid inhaling vapors

·cap tightly and store at room temperature away from heat

Active Ingredient

Salicylic acid 5%

Other Information

·store at room temperature

·avoid excessive heat 37°C (99°F)

·skin discoloration may accur during or after use

·wipe the tip of the tube with a paper towel between uses

Inactive Ingredients

Water,Glycerin,Podofilox,Polyethylene Glycol,Borneol,etc.

Principal Display Panel

Keep Oot of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Use

·for the removal of common and plantar warts

·the common wart is easily recognized by the rough “cauliflower-like” appearance on the surface.

·the plantar wart is recognized by its location only on the bottom of the foot, its tenderness and interruption of the footprint pattern

Purpose

Wart remover

Stop Use

and ask a doctor if

discomfort persists.

Warnings

For external use only. Flammable.

Keep away from fire and flame.

Ask Doctor

discomfort persists.

Directions

·wash affected area

·may soak wart in warm water for 5 minutes

·dry area thoroughly

·by squeezing tube gently, apply one drop at a time to sufficiently cover each wart

·let dry

·repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks

Do Not Use (Do not use)

·on irritated skin or on any area that is infected or reddened

·on moles, birthmarks, warts with hair growing from them, genital warts or warts on the face or mucous membranes.

·if you have diabetes or poor blood circulation.

When Using

·avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes.

·avoid inhaling vapors

·cap tightly and store at room temperature away from heat

Active Ingredient

Salicylic acid 5%

Other Information (Other information)

·store at room temperature

·avoid excessive heat 37°C (99°F)

·skin discoloration may accur during or after use

·wipe the tip of the tube with a paper towel between uses

Inactive Ingredients (Inactive ingredients)

Water,Glycerin,Podofilox,Polyethylene Glycol,Borneol,etc.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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