Active Ingredient
Menthol 0.2%
Restoral Ointment
FDA Label NDC 70983-022
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Saje Natural Business Inc. for the product Restoral (NDC 70983-022). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor, do not use, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations
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
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 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, vitis vinifera (grape seed) oil and witch hazel
Questions?
1-877-275-7253
Principle Display Panel Information
Restoral
topical analgesic ointment
net wt. 54.1g (1.91oz) and net wt. 13.5g (0.47oz)
* Please review the disclaimer below.
