Label: WARTS- 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
- NDC Code(s): 55714-2577-1
- Packager: Newton Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated December 19, 2022
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- INDICATIONS & USAGE SECTION
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DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begins with 1 pellet and gradually increase to full dose. WARNING: If bleeding or change in color or appearance occur, consult a licensed health professional.
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OTC - ACTIVE INGREDIENT SECTION
Equal parts of Taraxacum 6x, Thuja occ. 6x, Antimon. crud. 15x, Bryonia 15x, Calc.carb. 15x, Causticum 15x, Dulcamara 15x, Graphites 15x, Lycopodium 15x, Merc. sulph. rub. 15x, Nat. carb. 15x, Nitricum ac.15x, Nux vom. 15x, Rhus tox 15x, Sabina 15x, Sepia 15x, Silicea 15x, Staphysag. 15x, Sulphur 15x, Thuja occ. 15x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
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WARNINGS SECTION
WARNINGS: If bleeding or change in color or appearance occur, consult a licensed health professional.
WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
WARTS
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 pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2577 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE 15 [hp_X] in 1 g BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 15 [hp_X] in 1 g OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 15 [hp_X] in 1 g CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 15 [hp_X] in 1 g SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP 15 [hp_X] in 1 g GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 15 [hp_X] in 1 g LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 15 [hp_X] in 1 g MERCURIC SULFIDE (UNII: ZI0T668SF1) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC SULFIDE 15 [hp_X] in 1 g SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE 15 [hp_X] in 1 g NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID 15 [hp_X] in 1 g STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 15 [hp_X] in 1 g TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 15 [hp_X] in 1 g JUNIPERUS SABINA LEAFY TWIG (UNII: Z5BEX9K2G1) (JUNIPERUS SABINA LEAFY TWIG - UNII:Z5BEX9K2G1) JUNIPERUS SABINA LEAFY TWIG 15 [hp_X] in 1 g SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 15 [hp_X] in 1 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 15 [hp_X] in 1 g DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 15 [hp_X] in 1 g SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 15 [hp_X] in 1 g THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 15 [hp_X] in 1 g TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 6 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-2577-1 28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 12/19/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/19/2022 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-2577)
