83124-001

83124-001
SPL v1
SPL
SPL Set ID ee42c3f7-0b94-1380-e053-2a95a90a1d4b
Route
TOPICAL
Published
Effective Date 2022-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (40 g)
Inactive Ingredients
Lanolin Polyvinyl Acetate Petrolatum Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-11-25

Description

Salicylic acid 40%

Purpose

Wart Remover


Medication Information

Purpose

Wart Remover

Description

Salicylic acid 40%

Use(s)

for the removal of common warts. The common wart is easily recognized bythe rough 'cauliflower-like' appearance of the surface.

Directions

wash affected area.(optional: may soak wart in warm water for 5 minutes.

dry area thoroughly. (if appropriate: cut plaster to fit wart)

apply medicated plaster.

repeat procedure every 48 hours as needed unti wart is removed for up to 12 weeks.

Do Not Use

on irritated, infected or reddened skin

on genital warts and warts on the face

on moles, birthmarks and warts with hair growing from them

on mucous membranes

Purpose(s)

Wart Remover

Questions?

Call 1-646-798-1280

Warning(s)



Do not use

on irritated, infected or reddened skin

on genital warts and warts on the face

on moles, birthmarks and warts with hair growing from them

on mucous membranes

Ask a doctor before use if you have

diabetes

poor blood circulation

Stop use and ask a doctor if discomfort persists

Keep out of reach of children.

If swallowed, get medical help or contact a Poison control Center right away.

Package Label

42 PATCH in 1 BOX 83124-001-01

Other Information

store between 59° and 86°F(15°C and 30°C)

Active Ingredient(s)

Salicylic acid 40%

Inactive Ingredients

hard paraffin, lanolin, phenol, polyvinyl alkyl, vaseline

Stop Use and Ask A Doctor If

Stop use and ask a doctor if discomfort persists

Keep Out of Reach of Children.

Keep out of reach of children.

Ask A Doctor Before Use If You Have

diabetes

poor blood circulation


Structured Label Content

Use(s)

for the removal of common warts. The common wart is easily recognized bythe rough 'cauliflower-like' appearance of the surface.

Directions

wash affected area.(optional: may soak wart in warm water for 5 minutes.

dry area thoroughly. (if appropriate: cut plaster to fit wart)

apply medicated plaster.

repeat procedure every 48 hours as needed unti wart is removed for up to 12 weeks.

Do Not Use (Do not use)

on irritated, infected or reddened skin

on genital warts and warts on the face

on moles, birthmarks and warts with hair growing from them

on mucous membranes

Purpose(s)

Wart Remover

Questions?

Call 1-646-798-1280

Warning(s) (Warning(S))



Do not use

on irritated, infected or reddened skin

on genital warts and warts on the face

on moles, birthmarks and warts with hair growing from them

on mucous membranes

Ask a doctor before use if you have

diabetes

poor blood circulation

Stop use and ask a doctor if discomfort persists

Keep out of reach of children.

If swallowed, get medical help or contact a Poison control Center right away.

Package Label

42 PATCH in 1 BOX 83124-001-01

Other Information (Other information)

store between 59° and 86°F(15°C and 30°C)

Active Ingredient(s) (Active ingredient(S))

Salicylic acid 40%

Inactive Ingredients (Inactive ingredients)

hard paraffin, lanolin, phenol, polyvinyl alkyl, vaseline

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

Stop use and ask a doctor if discomfort persists

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

Keep out of reach of children.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

diabetes

poor blood circulation


Advanced Ingredient Data


Raw Label Data

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