NDC 49726-046 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

NDC Product Code 49726-046

NDC Code: 49726-046

Proprietary Name: Painazol What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: 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 What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 49726 - Hellolife, Inc.
    • 49726-046 - Painazol

NDC 49726-046-60

Package Description: 60 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Painazol with NDC 49726-046 is a a human over the counter drug product labeled by Hellolife, Inc.. The generic name of Painazol is 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. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Hellolife, Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Painazol Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACTAEA SPICATA ROOT 10 [hp_X]/1
  • HORSE CHESTNUT 10 [hp_X]/1
  • ARNICA MONTANA 10 [hp_X]/1
  • BELLIS PERENNIS 10 [hp_X]/1
  • BRYONIA ALBA ROOT 10 [hp_X]/1
  • OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X]/1
  • CALCIUM FLUORIDE 10 [hp_X]/1
  • CAUSTICUM 10 [hp_X]/1
  • BLACK COHOSH 10 [hp_X]/1
  • FORMIC ACID 10 [hp_X]/1
  • HYPERICUM PERFORATUM 10 [hp_X]/1
  • RHODODENDRON TOMENTOSUM LEAFY TWIG 10 [hp_X]/1
  • LITHIUM CARBONATE 10 [hp_X]/1
  • MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 10 [hp_X]/1
  • PHOSPHORUS 10 [hp_X]/1
  • PHYTOLACCA AMERICANA ROOT 10 [hp_X]/1
  • ANEMONE PRATENSIS 10 [hp_X]/1
  • RHODODENDRON AUREUM LEAF 10 [hp_X]/1
  • TOXICODENDRON PUBESCENS LEAF 10 [hp_X]/1
  • RUTA GRAVEOLENS FLOWERING TOP 10 [hp_X]/1
  • SALICYLIC ACID 10 [hp_X]/1
  • SEPIA OFFICINALIS JUICE 10 [hp_X]/1
  • SULFUR 10 [hp_X]/1
  • ZINC 10 [hp_X]/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Hellolife, Inc.
Labeler Code: 49726
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-28-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Painazol Product Label Images

Painazol Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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:

For the temporary relief of symptoms such as:• pain• burning• weakness• sensitivity• tingling• numbnessProduct indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.

For the temporary relief of symptoms such as:• pain• burning• weakness• sensitivity• tingling• numbnessProduct indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.

Warnings:

Stop use and as a doctor if symptoms persist or worsen.If pregnant or breast-feeding, ask a health professional before use.

Storage & Handling:

Do not store next to electrical devices or appliances.Keep lid tightly closed & store in a cool, dry place.

Directions:

Dissolve under tongue.30-50lb (13.6 kg-22.6kg): 1/2 tablet twice daily.50lb+ (22.6kg): 1 tablet twice daily.

Inactive Ingredients:

Advantol 300, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose.

Questions:

Dist. by: HelloLife, Inc.4635 40th St SEGrand Rapids, MI 49512Call us toll-free at:1-800-875-0850 or visit us onthe web at www.hellolife.net

Package Label Display:

NDC 49726-046-60PAINAZOLTABLETSNatural Relief forRespiratory SymptomsHomeopathic (OTC) Medicine60 Quick-dissolving Tablets

* Please review the disclaimer below.

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