Label: PAINAZOL (actaea spicata, aesculus hippocastanum, arnica montana, bellis perennis, bryonia (alba), calcarea carbonica, calcarea fluorica, causticum, cimicifuga racemosa, formicum acidum, hypericum perforatum, ledum palustre, lithium carbonicum, magnesia phosphorica, phosphorus, phytolacca decandra, pulsatilla- pratensis, rhododendron chrysanthum, rhus tox, ruta graveolens, salicylicum acidum, sepia, sulphur, zincum metallicum tablet
- NDC Code(s): 49726-046-60
- Packager: HelloLife, 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 November 16, 2022
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ACTIVE HPUS INGREDIENTS:
Actaea Spicata 10X, 20X, 30X, 200C, Aesculus Hippocastanum 10X, 20X, 30X, 200C, Arnica Montana 10X, 20X, 30X, 200C, Bellis Perennis 10X, 20X, 30X, 200C, Bryonia (Alba) 10X, 20X, 30X, 200C, Calcarea Carbonica 10X, 20X, 30X, 200C, Calcarea Fluorica 10X, 20X, 30X, 200C, Causticum 10X, 20X, 30X, 200C, Cimicifuga Racemosa 10X, 20X, 30X, 200C, Formicum Acidum 10X, 20X, 30X, 200C, Hypericum Perforatum 10X, 20X, 30X, 200C, Ledum Palustre 10X, 20X, 30X, 200C, Lithium Carbonicum 10X, 20X, 30X, 200C, Magnesia Phosphorica 10X, 20X, 30X, 200C, Phosphorus 10X, 20X, 30X, 200C, Phytolacca Decandra 10X, 20X, 30X, 200C, Pulsatilla (Pratensis) 10X, 20X, 30X, 200C, Rhododendron Chrysanthum 10X, 20X, 30X, 200C, Rhus Tox 10X, 20X, 30X, 200C, Ruta Graveolens 10X, 20X, 30X, 200C, Salicylicum Acidum 10X, 20X, 30X, 200C, Sepia 10X, 20X, 30X, 200C, Sulphur 10X, 20X, 30X, 200C, Zincum Metallicum 10X, 20X, 30X, 200C.
- INDICATIONS FOR USE:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN
- STORAGE & HANDLING:
- DIRECTIONS:
- INDICATIONS FOR USE:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
PAINAZOL
actaea spicata, aesculus hippocastanum, arnica montana, bellis perennis, bryonia (alba), calcarea carbonica, calcarea fluorica, causticum, cimicifuga racemosa, formicum acidum, hypericum perforatum, ledum palustre, lithium carbonicum, magnesia phosphorica, phosphorus, phytolacca decandra, pulsatilla (pratensis), rhododendron chrysanthum, rhus tox, ruta graveolens, salicylicum acidum, sepia, sulphur, zincum metallicum tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49726-046 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA ROOT 10 [hp_X] HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT 10 [hp_X] ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 10 [hp_X] BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 10 [hp_X] BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 10 [hp_X] OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X] CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 10 [hp_X] CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 10 [hp_X] BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 10 [hp_X] FORMIC ACID (UNII: 0YIW783RG1) (FORMIC ACID - UNII:0YIW783RG1) FORMIC ACID 10 [hp_X] HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 10 [hp_X] RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG 10 [hp_X] LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66) LITHIUM CARBONATE 10 [hp_X] MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 10 [hp_X] PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 10 [hp_X] PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 10 [hp_X] ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI) ANEMONE PRATENSIS 10 [hp_X] RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U) RHODODENDRON AUREUM LEAF 10 [hp_X] TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 10 [hp_X] SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 10 [hp_X] SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 10 [hp_X] SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 10 [hp_X] ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 10 [hp_X] Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) COPOVIDONE (UNII: D9C330MD8B) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49726-046-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/28/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/28/2019 Labeler - HelloLife, Inc. (065619378) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(49726-046) , api manufacture(49726-046) , label(49726-046) , pack(49726-046)