SPL v1
SPL
SPL Set ID 2ddf982a-e9ed-915d-e063-6394a90a7897
Route
TOPICAL
Published
Effective Date 2025-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1.5 g)
Inactive Ingredients
Glycerin Podofilox Water Polyethylene Glycol, Unspecified Borneol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-11

Description

Salicylic acid 5%

Purpose

Use for Corns Calluses Flat warts Plantar warts Common warts


Medication Information

Purpose

Use for

Corns

Calluses

Flat warts

Plantar warts

Common warts

Description

Salicylic acid 5%

Dosage

wash affected area·may soak wart inwarm water for 5 minutes

*dry area thoroughly·by squeezing tube gently, apply one dropat a time to sufficiently cover each wart.let dry

*repeat this procedure once or twice daily asneeded (until wart is removed)for up to 12weeks

Warning

Warnings

For external use only.Flammable-keepaway from fire and flames. Do not apply toirritated skin or any areas that are infectedor reddened. Avoid use on moles, birthmarks.warts with hair, genital warts, or warts onthe face or mucous membranes. Notrecommended for individuals with diabetesor poor blood circulation.

Package

Do Not Use

Do not apply toirritated skin or any areas that are infectedor reddened. Avoid use on moles, birthmarks,warts with hair, genital warts, or warts onthe face or mucous membranes. Notrecommended for individuals with diabetesor poor blood circulation

Active Ingredient

Salicylic acid 5%

Directions for Use

Directions for use

.wash affected area·may soak wart inwarm water for 5 minutes

*dry area thoroughly·by squeezing tube gently, apply one dropat a time to sufficiently cover each wart.let dry

*repeat this procedure once or twice daily asneeded (until wart is removed)for up to 12weeks

Inactive Ingredient

Borneol

Glycerin

Podofilox

Polyethylene Glycol

Water

When Using This Product

When using this product

avoid contact with eyes. lf product gets intothe eye,flush with water for 15minutes.·avoid inhaling vapors.cap tightly and storeat room temperature away from heat

Stop Use and Ask A Doctor

Stop use and ask a doctor if discomfort persists.

Keep Out of Reach of Children

Keep out of reach of childrenIf swallowed, get medical help or contact aPoison Control Center(1-800-222-1222)rightaway.


Structured Label Content

Dosage

wash affected area·may soak wart inwarm water for 5 minutes

*dry area thoroughly·by squeezing tube gently, apply one dropat a time to sufficiently cover each wart.let dry

*repeat this procedure once or twice daily asneeded (until wart is removed)for up to 12weeks

Purpose

Use for

Corns

Calluses

Flat warts

Plantar warts

Common warts

Warning

Warnings

For external use only.Flammable-keepaway from fire and flames. Do not apply toirritated skin or any areas that are infectedor reddened. Avoid use on moles, birthmarks.warts with hair, genital warts, or warts onthe face or mucous membranes. Notrecommended for individuals with diabetesor poor blood circulation.

Package (package)

Do Not Use (Do not use)

Do not apply toirritated skin or any areas that are infectedor reddened. Avoid use on moles, birthmarks,warts with hair, genital warts, or warts onthe face or mucous membranes. Notrecommended for individuals with diabetesor poor blood circulation

Active Ingredient

Salicylic acid 5%

Directions for Use (Directions for use)

Directions for use

.wash affected area·may soak wart inwarm water for 5 minutes

*dry area thoroughly·by squeezing tube gently, apply one dropat a time to sufficiently cover each wart.let dry

*repeat this procedure once or twice daily asneeded (until wart is removed)for up to 12weeks

Inactive Ingredient (Inactive ingredient)

Borneol

Glycerin

Podofilox

Polyethylene Glycol

Water

When Using This Product (When using this product)

When using this product

avoid contact with eyes. lf product gets intothe eye,flush with water for 15minutes.·avoid inhaling vapors.cap tightly and storeat room temperature away from heat

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

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 childrenIf swallowed, get medical help or contact aPoison Control Center(1-800-222-1222)rightaway.


Advanced Ingredient Data


Raw Label Data

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