The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Wartcalm (NDC 0220-9372). 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 - do not use, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients ** (in each tablet)
Antimonium crudum 9C HPUS (0.83 mg) (contains less than 10 -18 mg antimony)
Nitricum acidum 9C HPUS (0.83 mg)
Thuja occidentalis 9C HPUS (0.83 mg)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Purpose*
Antimonium crudum 9C HPUS (0.83 mg) ... For removal of warts with hard, rough surfaces that often appear in groups
Nitricum acidum 9C HPUS (0.83 mg) ... For removal of yellowish warts that sting
Thuja occidentalis 9C HPUS ... For removal of common warts and plantar warts
Uses*
Warnings
Do not use for moles, birthmarks, warts with hair growing on them, genital warts, or warts on the face or mucous membranes.
Stop use and ask a doctor if discomfort persists or if warts become painful, start multiplying quickly, or change in appearance.
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 6 years of age and older - Dissolve 2 tablets in the mouth 2 times a day, mornings and evenings, until wart is removed or as directed by a doctor. Daily use for at least 1 month is recommended.
Children 2 to 5 years of age - Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.
Children under 2 years of age - Ask a doctor.
croscarmellose sodium, lactose, magnesium stearate
BoironUSA.com
1-800-BOIRON-1
(1-800-264-7661)
Made in France
Distributed by Boiron Inc.
Newtown Square, PA 19073
do not use if glued carton end flaps are open or if the blister seal is broken
store below 86° F (30° C)
Wart Remover*
Common Wart Varieties Planter (Foot) Warts*
Non-scarring Wart Remover*
From the Inside Out
60 meltaway tablets unflavored
Meltaway Tablets Require No Food or Water
No Artificial Colors, Flavors, Sweeteners, or Preservatives
No Known Drug Interactions
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
* Please review the disclaimer below.
