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| Product NDC Code | 61480-125 | ||||||||||||||
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| Drug Name | Eczema |
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| Type | Brand | ||||||||||||||
| Pharm Class | Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||||||
| Dosage Form | TABLET, CHEWABLE | ||||||||||||||
| Labeler Name | PLYMOUTH HEALTHCARE PRODUCTS LLC | ||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredients (HPUS*) in each 600mg pill Purpose** Niccolum Sulphuricum 3X 300mg Itching, Scaling, Redness Kali Bromatum 1X 150mg Calming Effect Kali Muriaticum 1X 50mg Dryness, Redness, Scaling Hepar Sulphuris Calcareum 3X 28mg Skin Inflammation Kali Bichromicum 3X 28mg Skin Itching Kali Sulphuricum 3X 28mg Eczema Treatment Sulphur 1X 10mg Dry, Scaly, Itchy Skin *The letters "HPUS" indicate that these ingredients are officially monographed in the Homeopathic Pharmacopoeia of the United States. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
| Niccolum Sulphuricum 3X 300mg | Itching, Scaling, Redness |
| Calming Effect | |
| Kali Muriaticum 1X 50mg | Dryness, Redness, Scaling |
| Hepar Sulphuris Calcareum 3X 28mg | Skin Inflammation |
| Kali Bichromicum 3X 28mg | |
| Kali Sulphuricum 3X 28mg | Eczema Treatment |
| Sulphur 1X 10mg | Dry, Scaly, Itchy Skin |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions: Adults & Children 25 lbs & Up: Take ONCE per day as indicated on the chart below according to your weight: Weight Daily Dosage 25 - 50 lbs ......................... (.5) Pills Daily 50 - 100 lbs ....................... (1) Pills Daily 100 - 150 lbs ..................... (2) Pills Daily 150 - 200 lbs ..................... (3) Pills Daily Over 200 lbs ...................... (4) Pills Daily Over 250 lbs.......................(5) Pills Daily Chew pill & allow to dissolve in the mouth for 1-2 minutes before swallowing. Do not eat or drink anything for 10 minutes after swallowing for maximum effectiveness. Recommended treatment course: 2-4 weeks. Continue using as long as beneficial. Increase dosage by 50% if symptoms do not imporove after 1 week.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Magnesium Stearate, Maltodextrin, Natural Blueberry Flavor, Sucrose.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses: For the temporary relief of Eczema & Atopic Dermatitis symptoms.
Purpose
Information about the drug product’s indications for use.Naturally Helps Relive Itching Inflammation Naturally Helps Clear Eczema Naturally Helps Prevent Recurrences Steroid Free
Spl product data elements
Usually a list of ingredients in a drug product.ECZEMA Niccolum Sulphuricum, Kali Bromatum, Kali Muriaticum, Hepar Sulphuris Calcareum, Kali Bichromicum, Kali Sulphuricum, Sulphur. SUCROSE MALTODEXTRIN BLUEBERRY MAGNESIUM STEARATE NICKEL SULFATE HEXAHYDRATE NICKEL CATION POTASSIUM BROMIDE BROMIDE ION POTASSIUM CHLORIDE POTASSIUM CATION CALCIUM SULFIDE CALCIUM SULFIDE POTASSIUM DICHROMATE DICHROMATE ION POTASSIUM SULFATE SULFATE ION SULFUR SULFUR off-white with green speckles LL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.NDC# 61480-125-61 For Kids & Adults LOMALUX LABORATORIES ECZEMA PILL WELLNESS FROM WITHIN HEALTHY SKIN FORMULA Nathurally Helps Relieve Itching Inflammation 24 HOUR ONE DOSE Naturally Helps Clear Eczema Natural Berry Flavor Naturally Helps Prevent Recurrences Steroid Free 60 QUICK DISSOLVING PILLS HOMEOPATHIC ORAL MEDICATION Carton Label Naturally Helps Relive Itching Inflammation Naturally Helps Clear Eczema Naturally Helps Prevent Recurrences Steroid Free
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.For Kids & Adults Dermatologist Developed LOMALUX LABORATORIES ECZEMA PILL WE TARGET ECZEMA AT ITS SOURCE - WELLNESS FROM WITHIN As Eczema begins internally why use as a topical band aid? Just like your daily vitamin, Eczema Pill is taken orally to relieve eczema scaling and itching from the inside out for healthy skin from within. With just one daily dose, Eczema Pill's 7 all natural mineral ingredients help relieve all ezcema symptons for kids and adults weighing 25 lbs. & up. WHEN USED REGULARLY, MAY HELP RELIEVE ECZEMA SYMPTOMS NATURE CREATED - DERMATOLOGIST PERFECTED. We use only the finest quality ingredients in our exclusive formulation developed by our dermatologist founder to promote healthy skin from within. A perfect blend of science and nature. • NON-IRRITATING • NON-DRYING • STEROID FREE • NON DROWSY Made in USA NATURAL active ingredients LACTOSE FREE VEGAN GLUTEN FREE For Kids & Adults Dermatologist Developed LOMALUX LABORATORIES EXCLUSIVE MINERAL TECHNOLOGY PROMOTES SKIN HEALTH 7 Exclusive Active Mineral ingredients help relive eczema symptoms of scaling, itching & inflammation. These minerals are all natural, earth derived. FOR ADULTS & KIDS 25 lbs. & UP Gentle and effective for both kids and big kids alike. • NON-IRRITATING • NON-DRYING • STEROID FREE • NON DROWSY No harsh steroids, antihistamines that can cause drowsiness, or other irritating ingredients. CUSTOMIZED DOSAGE ACCORDING TO YOUR WEIGHT • FOR OPTIMAL RESULTS NATURAL active ingredients LACTOSE FREE VEGAN GLUTEN FREE
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information TAMPER EVIDENT for your protection do not use if blister is broken.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Call 800-316-9636, Monday through Friday, 9am - 5pm EST or visit www.lomalux.com Distributed by Loma Lux Laboratories: 6521 Davis Industrial Parkway, Solon OH 44139 USA
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings: DO NOT USE if you have kidney disease in children under 25 lbs if pregnant Ask a doctor before use if • you have a known sensitivity to nickel or costume jewelry. • a known sensitivity to any ingredients in this product. Stop use and ask a doctor if skin rash appears feelings of nervousness occur if condition worsens or does not imporve after regular use of this product. ----------------------------------------------------------------------------------------------------------------------------------------- If pregnant, do not use. If breast-feeding , ask a doctor before use. ----------------------------------------------------------------------------------------------------------------------------------------- Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.
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Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API