SPL v1
SPL
SPL Set ID fd363916-d1f9-9681-e053-6294a90a0b1e
Route
TOPICAL
Published
Effective Date 2023-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (7 g)
Inactive Ingredients
Hawthorn Leaf With Flower Sophora Flavescens Root Pseudolarix Amabilis Bark Stellera Chamaejasme Whole Lonicera Confusa Flower Cnidium Monnieri Fruit Podophyllum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-06-02

Description

Salicylic acid 7%

Purpose

Wart remover


Medication Information

Purpose

Wart remover

Description

Salicylic acid 7%

Use

to remove warts such as common warts, plantar warts, fat warts, corns, calluses

the common wart is easily recognized by the rough "cauliflower-like" appearance of the surface

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

Stop Use

if discomfort persists.

Warnings

For external use only.

Flammable. Keep away from fire and flame.

Questions

[email protected]

kronabeauty.com

Ask Doctor

if discomfort persists.

Directions

wash the affected area

may soak the wart in warm water for 5 minutes

dry area thoroughly

using the applicator(brush or cotton swab), apply one drop at a time to sufficiently cover each wart

allow it to fully absorb and let dry

repeat this procedure once or twice daily as needed (until the 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, warts on the face or mucous membranes

if you have diabetes or poor blood circulation

When Using

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

avoid inhaling vapors

cap the bottle tightly and store at room temperature away from heat

out of direct sunlight

Active Ingredient

Salicylic acid 7%

Other Information

store at room temperature

avoid excessive heat 37°C(99°F)

skin discoloration any occur during or after use

wipe the rim of the bottle with a paper towel between uses

Inactive Ingredients

Ageratina herbacea, Hawthorn leaf with flower, Lonicera confusa flower, Podophyllum hexandrum root, Pseudolarix amabilis bark, Sophora pachycarpa, Thyme

Keep Oot of Reach of Children

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

Package Label Principal Display Panel


Structured Label Content

Use

to remove warts such as common warts, plantar warts, fat warts, corns, calluses

the common wart is easily recognized by the rough "cauliflower-like" appearance of the surface

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

Purpose

Wart remover

Stop Use

if discomfort persists.

Warnings

For external use only.

Flammable. Keep away from fire and flame.

Questions

[email protected]

kronabeauty.com

Ask Doctor

if discomfort persists.

Directions

wash the affected area

may soak the wart in warm water for 5 minutes

dry area thoroughly

using the applicator(brush or cotton swab), apply one drop at a time to sufficiently cover each wart

allow it to fully absorb and let dry

repeat this procedure once or twice daily as needed (until the 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, warts on the face or mucous membranes

if you have diabetes or poor blood circulation

When Using

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

avoid inhaling vapors

cap the bottle tightly and store at room temperature away from heat

out of direct sunlight

Active Ingredient

Salicylic acid 7%

Other Information (Other information)

store at room temperature

avoid excessive heat 37°C(99°F)

skin discoloration any occur during or after use

wipe the rim of the bottle with a paper towel between uses

Inactive Ingredients (Inactive ingredients)

Ageratina herbacea, Hawthorn leaf with flower, Lonicera confusa flower, Podophyllum hexandrum root, Pseudolarix amabilis bark, Sophora pachycarpa, Thyme

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.

Package Label Principal Display Panel (PACKAGE LABEL - PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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