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Restoral - Medication Information

Product NDC Code 69204-023
Drug Name

Restoral

Type Brand
Active Ingredients
Menthol .2 g/100g
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 418609
Application Number part348
Labeler Name Natures Formulae Health Products Ltd.
Packages
Package NDC Code Description
69204-023-01 1 container in 1 box (69204-023-01) / 54.1 g in 1 container
69204-023-02 13.5 g in 1 container (69204-023-02)
Check if available Online

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 PROPOLIS WAX OLIVE OIL COMFREY ROOT PEPPERMINT OIL YELLOW WAX ST. JOHN'S WORT STELLARIA MEDIA TRIFOLIUM PRATENSE FLOWER ALTHAEA OFFICINALIS ROOT LARREA TRIDENTATA LEAF BERBERIS AQUIFOLIUM ROOT CALENDULA OFFICINALIS FLOWER EUCALYPTUS OIL TEA TREE OIL AGRIMONIA EUPATORIA LEAF QUERCUS ALBA BARK ROSEMARY WITCH HAZEL MENTHOL MENTHOL MATRICARIA CHAMOMILLA FLOWERING TOP LOBELIA INFLATA 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 Restoral box 54.1g (1) Restoral box 54.1g (2) Restoral 13.5g box Restoral Drug Facts box

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 feeding
if 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