81799-004

81799-004
SPL v1
SPL
SPL Set ID ebda9663-5e58-05f2-e053-2995a90a6f96
Route
TOPICAL
Published
Effective Date 2022-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (12 mg)
Inactive Ingredients
Coptis Chinensis Root Water Phellodendron Amurense Bark Brucea Javanica Fruit Borneol Triclosan Lonicera Japonica Top

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-10-25

Description

Salicylic Acid 12%

Purpose

Wart remover


Medication Information

Purpose

Wart remover

Description

Salicylic Acid 12%

Use

use :

for the removal of common and plantar warts

the common war is easy ily recognized by the rough macauli flowerlike " appearance of the surface

the plantar wart is recognized by its location only on the bottom ofthe foot . its tenderness and the interru option of the foot pró nt pattern

Section 50565-1

Keep out of reach of children

If product gets into eyes , flush with water for 15 minutes

IF swallowed , get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor

if discomfort persists

Section 50567-7

Ask a doctor before you use

if you have diabetes or poor blood circulation

Stop use and ask a doctor

if discomfort persists

Keep out of reach of children

If product gets into eyes , flush with water for 15 minutes

IF swallowed , get medical help or contact a Poison Control Center right away

Warnings

Warnings

For externall use

Directions

Directions :

Wash the affected area and dry it

Apply this product with a cotton swab to the wart

Repeat this procedure 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

Do not use on moles skin tags , birthmarks , warts with hair growing from them , genital warts , or warts on the face or mucous membranes

Other Information

Other information

Store at room temperature and out of direct sunlight

skin discoloration may occur during or affter use

Active Ingredient(s)

Salicylic Acid 12%

Inactive Ingredients

Water

BRUCEA JAVANICA FRUIT

Coptis Chinensis Root Extract

Phellodendron Amurense Bark Extract

LONICERA JAPONICA TOP

Triclosan

Borneol

Package Label Principal Display Panel

81799-004-01


Structured Label Content

Use

use :

for the removal of common and plantar warts

the common war is easy ily recognized by the rough macauli flowerlike " appearance of the surface

the plantar wart is recognized by its location only on the bottom ofthe foot . its tenderness and the interru option of the foot pró nt pattern

Section 50565-1 (50565-1)

Keep out of reach of children

If product gets into eyes , flush with water for 15 minutes

IF swallowed , get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor

if discomfort persists

Section 50567-7 (50567-7)

Ask a doctor before you use

if you have diabetes or poor blood circulation

Stop use and ask a doctor

if discomfort persists

Keep out of reach of children

If product gets into eyes , flush with water for 15 minutes

IF swallowed , get medical help or contact a Poison Control Center right away

Purpose

Wart remover

Warnings

Warnings

For externall use

Directions

Directions :

Wash the affected area and dry it

Apply this product with a cotton swab to the wart

Repeat this procedure twice daily as needed ( until wart is removed ) for up to 12 weeks

Do Not Use (Do not use)

Do not use

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

Do not use on moles skin tags , birthmarks , warts with hair growing from them , genital warts , or warts on the face or mucous membranes

Other Information (Other information)

Other information

Store at room temperature and out of direct sunlight

skin discoloration may occur during or affter use

Active Ingredient(s)

Salicylic Acid 12%

Inactive Ingredients (Inactive ingredients)

Water

BRUCEA JAVANICA FRUIT

Coptis Chinensis Root Extract

Phellodendron Amurense Bark Extract

LONICERA JAPONICA TOP

Triclosan

Borneol

Package Label Principal Display Panel (Package Label - Principal Display Panel)

81799-004-01


Advanced Ingredient Data


Raw Label Data

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