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| Product NDC Code | 75071-010 | ||||
|---|---|---|---|---|---|
| Drug Name | Eco lips menthol medicated lip balm |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| RxCUI drug identifier | 418610 | ||||
| Application Number | M017 | ||||
| Labeler Name | Eco Lips, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 1%
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 2 years of age and older: apply a small amount of product to affected area not more than 3 to 4 times daily wash hands before and after applying balm do not share product with anyone else children under 2 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients *Beeswax, *Calendula Flower Extract, *Chamomile Extract, ⴕ*Cocoa Butter, ⴕ*Coconut Oil, *Echinacea Root Extract, *Eucalyptus Oil, *Licorice Root Extract, *Lemon Balm Leaf Extract, *Peppermint Oil, *Tea Tree Oil, Mixed Tocopherols. *Certified Organic Ingredient ⴕFair Trade Certified™ by Fair Trade USA.® 20% of Product.
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 pain and itching associated with fever blisters and cold sores.
Purpose
Information about the drug product’s indications for use.Purpose Fever blister / cold sore treatment
Spl product data elements
Usually a list of ingredients in a drug product.Eco Lips Menthol Medicated Lip Balm Menthol SUNFLOWER OIL TEA TREE OIL CHAMOMILE FLOWER OIL COCOA BUTTER ROSEMARY OIL MENTHOL MENTHOL PEPPERMINT OIL COCONUT OIL TOCOPHEROL CALENDULA OFFICINALIS FLOWER YELLOW WAX MELISSA OFFICINALIS LEAF OIL EUCALYPTUS OIL ECHINACEA ANGUSTIFOLIA ROOT ST. JOHN'S WORT LICORICE
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.Carton artwork Eco Lips Menthol Medicated Fever Blister and Cold Sore Treatment Lip Balm Carton Artwork 0.15 oz
Label artwork Eco Lips Menthol Medicated Fever Blister and Cold Sore Treatment 0.15 oz lip balm tube label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.The following updates were incorporated into the product labeling beginning 7/2024 Uses For the temporary relief of pain and itching associated with fever blisters and cold sores. Directions adults & children 2 years of age and older: apply a small amount of product to affected area not more than 3 to 4 times daily wash hands before and after applying balm do not share product with anyone else children under 2 years of age: ask a doctor
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.Drug Facts
Carton Text ECO LIPS PLANTPOD PLASTIC FREE TUBE MENTHOL MEDICATED FEVER BLISTER/COLD SORE TREATMENT FAST RELIEF OF ITCHING & PAIN WITH TEA TREE, LEMON BALM & PEPPERMINT Soothe painful and itchy fever blisters and cold sores with this special medicated lip care blend. Menthol and lemon balm work together providing a cool soothing effect to promote relief. Net Wt. .15 Oz (4.25 g) ECO LIPS, INC. CEDAR RAPIDS, IA 52402 ECOLIPS.COM CERTIFIED ORGANIC BY OREGON TILTH MANUFACTURED IN USA 100% PLASTIC FREE SPREAD THE GOOD
Label text ECO LIPS MENTHOL MEDICATED FEVER BLISTER/COLD SORE TREATMENT WITH TEA TREEE, LEMON BALM & PEPPERMINT PLANTPOD PLASTIC FREE TUBE Net Wt. 0.15 oz (4.25g) ECO LIPS, INC. CEDAR RAPIDS, IA 52402 ECOLIPS.COM CERTIFIED ORGANIC BY OREGON TILTH MANUFACTURED IN USA Peel here for drug facts
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. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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 1-866-326-5477, Monday-Friday, 8 a.m. to 5 p.m. CST
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with eyes
Storage and handling
Information about safe storage and handling of the drug product.Other information protect from excessive heat and direct sunlight
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 For external use only When using this product avoid contact with eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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