Otc - Active Ingredient
Drug Facts
Active Ingredient(in step 1)...................... Alcohol 60%
Active Ingredient(in step 2) ............. Salicylic Acid 17%
Verucide Wart Remover Kit
FDA Label NDC 63347-720
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Blaine Labs Inc. for the product Verucide Wart Remover Kit (NDC 63347-720). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, otc - when using, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Alcohol 60% (step 1) ............................................................... Antiseptic
Salicylic Acid 17% (step 2) ................................................ Wart Remover
Indications & Usage
Uses
■
(for step 1)Antiseptic to decrease bacteria on the skin
■
(for step 2)For the removal of common warts. The common wart is
easily recognized by the rough “cauliflower-like” appearance of the
surface ■ For the removal of plantar warts on the bottom of the foot. The
plantar wart is recognized by its location only on the bottom of the foot,
its tenderness, and the interruption of the footprint pattern
Warnings
Warnings-
For external use only (for step 1 & 2)
Extremely flammable. Keep away from fire or flames
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.Stop use and consult a doctor if discomfort
persists. Avoid contact with the eyes. If contact with eye occurs, wash
thoroughly with water
Otc - When Using
When using step 2, do not use: on irritated skin, any area that is infected or
reddened, if you are diabetic, have poor blood circulation, moles, birthmarks,
genital warts, warts with hair growing from them, warts on the face, or
mucous membranes
If swallowed, get medical help or contact a poison control center
right away 1-800-222-1222
Dosage & Administration
Directions
■
(for step 1)Wash the affected area
with one or two drops
■ (
for step 2)Clean using step 1 and
allow area to dry. Apply a small
amount at a time with applicator to
sufficiently cover each wart and let
dry ■ Let dry ■ Repeat this procedure
once or twice daily as needed (until
wart is removed) for up to 12 weeks
Other Safety Information
Other Information
Store at room temperature: 20-27°C
(68-81°F)
Inactive Ingredient
Inactive Ingredients
(for step 1)
Glycerin, Hydroxypropyl Cellulose,
Lavandula Angustifolia (Lavender)
Flower Extract, Purified Water
(for step 2)
Alcohol (Ethanol), Artemisia
Absinthium (Wormwood) Extract,
Carica Papaya (Papaya) Fruit Extract,
Glycerin, Hydroxypropyl Cellulose,
Purified Water
Otc - Questions
Questions or Comments?
800.307.8818 | BlaineLabs.com
M-F, 7:30 AM - 4:00 PM (pst)
[email protected]
Verucide ®Wart Remover Kit Labeling
BLAINE LABS ` NDC 63347-720-01
VERUCIDE
®
WART REMOVER
TWO-STEP WART TREATMENT KIT
SALICYLIC ACID
IN A SOLUTION CONTAINING
ALCOHOL AND PAPAYA EXTRACT
KIT INCLUDES:
STEP 1: 0.253 FL OZ (7.5 mL)
STEP 2: 0.101 FL OZ (3.0 mL)
Manufactured By:
Blaine Labs, Inc.
11037 Lockport Place
Santa Fe Springs, CA 90670
res
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