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| Product NDC Code | 83570-500 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Owell naturals pain relief cream |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | CREAM | ||||||||||
| RxCUI drug identifier | 727161 | ||||||||||
| Application Number | M017 | ||||||||||
| 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.Menthol 8%
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 Water, Carthamus tinctorius (Hybrid Safflower) Seed Oil, Helianthus annuus (Sunflower) Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Aloe barbadensis (Aloe Vera) Leaf Juice, Beeswax, Hydro- genated Castor Oil, Caprylyl Glycol, Phenoxyethanol, Eucalyptus globulus Leaf Oil, Chlorphenesin, Cinnamomum camphora Bark Oil, Abies sibirica Needle Oil, Methyl Salicylate, Sodium Chloride
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.Arthritis Pain, Sore Joints and Muscles, Sore Throat, Sinus Trouble, Restless Leg Syndrome
Purpose
Information about the drug product’s indications for use.Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Owell Naturals Pain Relief Cream Menthol SUNFLOWER SEED OIL GLYCERETH-8 ESTERS PEG-8 BEESWAX CAPRYLYL GLYCOL ABIES SIBIRICA LEAF OIL WATER CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) EUCALYPTUS GLOBULUS LEAF CINNAMOMUM CAMPHORA WHOLE SODIUM CHLORIDE ALOE VERA LEAF MENTHOL MENTHOL METHYL SALICYLATE SAFFLOWER OIL CHLORPHENESIN HYDROGENATED CASTOR OIL PHENOXYETHANOL
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.Owell Pain Relief Cream
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.
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. 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 Ask a doctor before use if you have redness over the affected area. When Using This Product ■ avoid contact with eyes or other sensitive areas ■ do not bandage tightly 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 Keep out of reach of children to avoid accidental ingestion. If swal- lowed, get medical help or contact a Poison Control Center immediately.
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