Warts - Moles - Skin Tags
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2011-06-01
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:05:10
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Warts - Moles - Skin Tags Formulated for various types of skin conditions such as warts (including genital), moles, keloids, molluscum and skin tags.
DOSAGE & ADMINISTRATION SECTION
Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.
ACTIVE INGREDIENT SECTION
Antimon. crud. 20x, Bryonia 20x, Calc.carb. 20x, Causticum 20x, Dulcamara 20x, Graphites 20x, Lycopodium 20x, Merc. sulph. rub. 20x, Nat. carb. 20x, Nitricum ac. 20x, Nux vom. 20x, Rhus toxicodendron 20x, Sabina 20x, Sepia 20x, Silicea 20x, Staphysag. 20x, Sulphur 20x, Thuja occ. 20x, Taraxacum 8x, Thuja occ. 8x, Taraxacum 3x, Thuja occ. 3x.
PURPOSE SECTION
Formulated for various types of skin conditions such as warts (including genital), moles, keloids, molluscum and skin tags.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.
QUESTIONS? SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256
WARNINGS SECTION
Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.
PREGNANCY OR BREAST FEEDING SECTION
Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days
KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
PACKAGE LABEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-4533-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d294-f424-e053-dadaa90a57ce | Warts - Moles - Skin Tags |
| 55714-4533-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d294-f424-e053-dadaa90a57ce | Warts - Moles - Skin Tags |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4533-1 | Warts - Moles - Skin Tags | 28.35 g in 1 BOTTLE, GLASS | PELLET | 28.35 | 1 | |
| 55714-4533-2 | Warts - Moles - Skin Tags | 56.7 g in 1 BOTTLE, GLASS | PELLET | 56.7 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-4533 | WARTS - MOLES - SKIN TAGS (ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC.,TARAXACUM) PELLET [NEWTON LABORATORIES, INC.] | 1 | Legacy NDC, 2 package rows | 20131107_5465a1ad-e29f-21a7-1f51-fb3bdb481f20.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Antimony Trisulfide | ACTIVE INGREDIENT | F79059A38U | 1 | |
| Bryonia Alba Root | ACTIVE INGREDIENT | T7J046YI2B | 1 | |
| Causticum | ACTIVE INGREDIENT | DD5FO1WKFU | 1 | |
| Delphinium Staphisagria Seed | ACTIVE INGREDIENT | 00543AP1JV | 1 | |
| Graphite | ACTIVE INGREDIENT | 4QQN74LH4O | 1 | |
| Juniperus Sabina Leafy Twig | ACTIVE INGREDIENT | Z5BEX9K2G1 | 1 | |
| Lycopodium Clavatum Spore | ACTIVE INGREDIENT | C88X29Y479 | 1 | |
| Mercuric Sulfide | ACTIVE INGREDIENT | ZI0T668SF1 | 1 | |
| Nitric Acid | ACTIVE INGREDIENT | 411VRN1TV4 | 1 | |
| Oyster Shell Calcium Carbonate, Crude | ACTIVE INGREDIENT | 2E32821G6I | 1 | |
| Sepia Officinalis Juice | ACTIVE INGREDIENT | QDL83WN8C2 | 1 | |
| Silicon Dioxide | ACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Sodium Carbonate | ACTIVE INGREDIENT | 45P3261C7T | 1 | |
| Solanum Dulcamara Top | ACTIVE INGREDIENT | KPS1B1162N | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE INGREDIENT | 269XH13919 | 1 | |
| Sulfur | ACTIVE INGREDIENT | 70FD1KFU70 | 1 | |
| Taraxacum Officinale | ACTIVE INGREDIENT | 39981FM375 | 1 | |
| Thuja Occidentalis Leafy Twig | ACTIVE INGREDIENT | 1NT28V9397 | 1 | |
| Toxicodendron Pubescens Leaf | ACTIVE INGREDIENT | 6IO182RP7A | 1 | |
| Antimony Trisulfide | ACTIVE MOIETY | F79059A38U | 1 | |
| Bryonia Alba Root | ACTIVE MOIETY | T7J046YI2B | 1 | |
| Carbonate Ion | ACTIVE MOIETY | 7UJQ5OPE7D | 1 | |
| Causticum | ACTIVE MOIETY | DD5FO1WKFU | 1 | |
| Delphinium Staphisagria Seed | ACTIVE MOIETY | 00543AP1JV | 1 | |
| Graphite | ACTIVE MOIETY | 4QQN74LH4O | 1 | |
| Juniperus Sabina Leafy Twig | ACTIVE MOIETY | Z5BEX9K2G1 | 1 | |
| Lycopodium Clavatum Spore | ACTIVE MOIETY | C88X29Y479 | 1 | |
| Mercuric Cation | ACTIVE MOIETY | ED30FJ8Y42 | 1 | |
| Nitric Acid | ACTIVE MOIETY | 411VRN1TV4 | 1 | |
| Oyster Shell Calcium Carbonate, Crude | ACTIVE MOIETY | 2E32821G6I | 1 | |
| Sepia Officinalis Juice | ACTIVE MOIETY | QDL83WN8C2 | 1 | |
| Silicon Dioxide | ACTIVE MOIETY | ETJ7Z6XBU4 | 1 | |
| Solanum Dulcamara Top | ACTIVE MOIETY | KPS1B1162N | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE MOIETY | 269XH13919 | 1 | |
| Sulfur | ACTIVE MOIETY | 70FD1KFU70 | 1 | |
| Taraxacum Officinale | ACTIVE MOIETY | 39981FM375 | 1 | |
| Thuja Occidentalis Leafy Twig | ACTIVE MOIETY | 1NT28V9397 | 1 | |
| Toxicodendron Pubescens Leaf | ACTIVE MOIETY | 6IO182RP7A | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 |
Products#
Every source-derived product name is available through these pages.
- Warts - Moles - Skin Tags
- Antimon. crud., Bryonia, Calc.carb., Causticum, Dulcamara, Graphites, Lycopodium, Merc. sulph. rub., Nat. carb., Nitricum ac., Nux vom., Rhus toxicodendron, Sabina, Sepia, Silicea, Staphysag., Sulphur, Thuja occ.,Taraxacum
- Antimony Trisulfide
- Bryonia Alba Root
- Oyster Shell Calcium Carbonate, Crude
- Causticum
- Solanum Dulcamara Top
- Graphite
- Lycopodium Clavatum Spore
- Mercuric Sulfide
- Mercuric Cation
- Sodium Carbonate
- Carbonate Ion
- Nitric Acid
- Strychnos Nux-vomica Seed
- Toxicodendron Pubescens Leaf
- Juniperus Sabina Leafy Twig
- Sepia Officinalis Juice
- Silicon Dioxide
- Delphinium Staphisagria Seed
- Sulfur
- Thuja Occidentalis Leafy Twig
- Taraxacum Officinale
- Sucrose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4533 | 55714-4533-1, 55714-4533-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Sucrose | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| Sucrose | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| Sucrose | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| Sucrose | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| af04301f-424e-b8ea-810b-1569d3e1d05a | 5465a1ad-e29f-21a7-1f51-fb3bdb481f20 | 2011-06-01 | Warnings | af04301f-424e-b8ea-810b-1569d3e1d05a 5465a1ad-e29f-21a7-1f51-fb3bdb481f20 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
