The following Structured Product Label (SPL) was submitted to the FDA by Shengnan (guangzhou) Cosmetics Co., Ltd for the product Wart Remover (NDC 84019-047). 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 warnings, otc - purpose, otc - stop use, otc - active ingredient, otc - when using, inactive ingredient, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Warnings
. For external use only. . Flammable Keep away from fire and flame.
.Keep out of reach of children.
.Avoid contact with eyes, in case of
contact, flush eyes with plenty
ofcool water.
.Do not swallow, if swallowed,seek medical attention or contact a Poison Control Center(1-800-222-1222) im-mediately.
Uses
For the removal of warts, including plantar warts, flat warts, common warts, corns, and calluses.
Do not use
. On broken skin or the area around
the eyes.
. On irritated skin or on any area that
is infected or reddened.
Salicylic Acid 40%
Discontinue use and consult a doctor if:
· You become pregnant or are trying to become pregnant while using this product.
· Irritation or redness occurs,worsens, or does not improve with continued use.
Inactive Ingredients:
Water, Borneol, Glycerin,
Polyethylene Glycol Bisabolol,
Allantoin, Lonicera Japonica
(Hon-ysuckle) Flower Extract,
Sophora Angusti-folia Root
Extract, Bee Venom.
-Repeat these steps two to three
times daily as needed (until the
wart is removed)for up to 12 weeks.
Directions: .Wash affected area. Soak the wart in warm water for 5 minutes(optional).
. Use a cotton swab to apply a sufficient amount to cover each wart. Let it dry.
.Repeat these steps two to three times daily as needed (until the wart is removed)for up to 12 weeks.
Other Warnings
· Children should use this product
under adult supervision.
· Avoid prolonged exposure to air
during use as the substance may
dissolve and crystallize easily.
.Recap immediately after each
use,Do not use if the cap is broken
or missing.
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