83871-002

83871-002
SPL v1
SPL
SPL Set ID 0ef3adb5-7247-0baa-e063-6394a90a117e
Route
TOPICAL
Published
Effective Date 2024-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 g)
Inactive Ingredients
Aloe Propylene Glycol Erythritol Glycerin Water Dimethyl Isosorbide Phenoxyethanol Glyceryl 1,2-dioleate, (s)- Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-14

Description

Salicylic Acid 1.0%

Purpose

Wart remover


Medication Information

Purpose

Wart remover

Description

Salicylic Acid 1.0%

Use

for the removal of corns, calluses, plantar warts, flat warts, common warts(less than 5 mm in size).

Stop Use

Stop use and ask a doctor:

• If you become pregnant, or are planning to become pregnant, while using the product.

• if discomfort persists.

Warnings

For external use only.

Flammable: Keep away from fire or flame.

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

Questions

Website: artimore.us

Email: [email protected]

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.

• if you are allergic to any of the ingredients in this product.

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.

• out of direct sunlight and store at room temperature away from heat.

Active Ingredient

Salicylic Acid 1.0%

Other Information

• store between 20° to 25° C(68° to 77° F) .

• keep tightly closed.

Inactive Ingredients

Water, Alcohol, Glycerin, Propylene Glycol, Dimethyl Isosorbide, Erythritol, Phenoxyethanol, Aloe Yohjyu Matsu Ekisu, Glyceryl Glucoside, Portulaca Oleracea Extract, Gentiana Scabra Root Extract, Xanthan Gum, Retinoic Acid, Dipotassium Glycyrrhizate

Principal Display Panel

Keep Oot of Reach of Children

Keep out 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 corns, calluses, plantar warts, flat warts, common warts(less than 5 mm in size).

Purpose

Wart remover

Stop Use

Stop use and ask a doctor:

• If you become pregnant, or are planning to become pregnant, while using the product.

• if discomfort persists.

Warnings

For external use only.

Flammable: Keep away from fire or flame.

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

Questions

Website: artimore.us

Email: [email protected]

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.

• if you are allergic to any of the ingredients in this product.

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.

• out of direct sunlight and store at room temperature away from heat.

Active Ingredient

Salicylic Acid 1.0%

Other Information (Other information)

• store between 20° to 25° C(68° to 77° F) .

• keep tightly closed.

Inactive Ingredients (Inactive ingredients)

Water, Alcohol, Glycerin, Propylene Glycol, Dimethyl Isosorbide, Erythritol, Phenoxyethanol, Aloe Yohjyu Matsu Ekisu, Glyceryl Glucoside, Portulaca Oleracea Extract, Gentiana Scabra Root Extract, Xanthan Gum, Retinoic Acid, Dipotassium Glycyrrhizate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Keep out 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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