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| Product NDC Code | 70983-022 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Restoral |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OINTMENT | ||||||
| RxCUI drug identifier | 418609 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | Saje Natural Business 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 0.2%
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Principle Display Panel information Restoral topical analgesic ointment net wt. 54.1g (1.91oz) and net wt. 13.5g (0.47oz)
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 and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Not recommended for children under 12 years of age.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Agrimonia eupatoria leaf extract, althaea officinalis root extract, beeswax (yellow), berberis aquifolium extract, calendula officinalis flower, chamomilla recutita (matricaria) flower extract, eucalyptus oil, larrea tridentata extract, lobelia inflata extract (lobelia), melaleuca alternifolia (tea tree) leaf oil, olive oil, peppermint oil, propolis extract, quercus alba bark extract, rosmarinus officinalis (rosemary) leaf extract, St. John’s wort, stellaria media (chickweed) extract, symphytum officinalis leaf extract, trifolium pratense (clover) flower extract and witch hazel
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 minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Restoral Menthol MATRICARIA CHAMOMILLA FLOWERING TOP LOBELIA INFLATA LEAF OLIVE OIL COMFREY ROOT PEPPERMINT OIL PEPPERMINT ST. JOHN'S WORT STELLARIA MEDIA TRIFOLIUM PRATENSE FLOWER MENTHOL MENTHOL ALTHAEA OFFICINALIS ROOT YELLOW WAX BERBERIS AQUIFOLIUM ROOT CALENDULA OFFICINALIS FLOWER EUCALYPTUS OIL LARREA TRIDENTATA LEAF TEA TREE OIL PROPOLIS WAX QUERCUS ALBA BARK ROSEMARY WITCH HAZEL AGRIMONIA EUPATORIA LEAF
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.Restoral Topical analgesic ointment - Outer label 2019 RESTORAL_54.1g_DFB 2019 RESTORAL_15ml_DFB 2019 RESTORAL_drugfactsbox
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 If allergic to marshmallow root or chickweed
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 product is swallowed, get medical help or contact a Poison Control Centre right away
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 if symptoms persist for 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 and mucous membranes; if this happens, rinse with vegetable oil
References
This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions.Questions? 1-877-275-7253
Pregnancy or breast feeding
Pregnancy or Breast feedingif pregnant or breast-feeding ask a health professional before use
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 Flammable - keep away from fire or flame Use may result in increased topical anti-inflammatory effects of steroids, due to presence of marshmallow herb When using this product Avoid contact with eyes and mucous membranes; if this happens, rinse with vegetable oil Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days Do not use On wounds or damaged skin If allergic to marshmallow root or chickweed if pregnant or breast-feeding ask a health professional before use keep out of reach of children if product is swallowed, get medical help or contact a Poison Control Centre right away
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