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| Product NDC Code | 83570-491 | ||||
|---|---|---|---|---|---|
| Drug Name | Owell naturals draw salve with camphor |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SALVE | ||||
| Labeler Name | Owell Naturals Brand LLC | ||||
| 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.CAMPHORA [HPUS]
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 Use only as directed adults and children 12 years of age and older, apply to affected area children under 12 years of age, ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Arnica Montana Flower Extract, Beeswax, Boswellia carterii (Frankincense) Oil, Calendula Officinalis (Marigold) Extract, Eucalyptus Oil, Lavandula angustifolia (Lavender) Oil, Melaleuca alternifolia (Tea Tree) Oil, Methyl Salicylate, Olea Europaea (Olive) Fruit Oil, Pinus sylvestris (Pine) Leaf Oil, Ricinus communis (Castor) Seed Oil, Silica, Symphytum Officinale (Comfrey) Leaf Extract
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 temporarily relieves minor aches and pains associated with Boils Cysts Splinters Thorns Ingrown Hairs Pain Itch & Irritation Relief Dry Skin Insect Bites Bee Sting Cuts Poison Ivy/Oak Burns
Purpose
Information about the drug product’s indications for use.External Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Owell Naturals Draw Salve with Camphor Camphor WHITE WAX CALENDULA OFFICINALIS FLOWER ARNICA MONTANA FLOWER LAVENDER OIL TEA TREE OIL WHITE PINE OIL EUCALYPTUS OIL OLIVE OIL CASTOR OIL FRANKINCENSE OIL METHYL SALICYLATE CAMPHOR (NATURAL) CAMPHOR (NATURAL) COMFREY LEAF SILICON DIOXIDE
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.NEW LABEL ART OWELL DRAW SALVE W CAMPHORA AND NEW TEXT 1.0 Camphora w NEW TEXT
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.Uses No Major Changes. This is a Second product for this client. Doses and Administration. No major changes
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have redness over the affected area
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not Use on wounds or damaged skin with a heating pad on a child under 12 years of age with arthritis-like conditions
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 to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.store at room temperature
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Customer Care: www.owellnaturals.com
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 or symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive skin irritation occurs
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 or other sensitive areas do not bandage tightly
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.Allergy Alert: If prone to allergic reaction from aspirin or salicylate, consult your doctor before using. Do Not Use: on wounds or damaged skin with a heating pad on a child under 12 years of age with arthritis-like conditions Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days
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