Restoral

Manufacturer
Natures Formulae Health Products Ltd.
Effective date
2016-10-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:48:59

Label at a glance#

ProductRestoral
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.2%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

Avoid contact with eyes and mucous membranes; if this happens, rinse with vegetable oil

Stop use and ask a doctor

OTC - STOP USE SECTION

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

OTC - DO NOT USE SECTION

On wounds or damaged skin

If allergic to marshmallow root or chickweed

if pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if product is swallowed, get medical help or contact a Poison Control Centre right away

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

Questions?

REFERENCES SECTION

1-877-275-7253

Principle Display Panel information

DESCRIPTION SECTION

Restoral

topical analgesic ointment

net wt. 54.1g (1.91oz) and net wt. 13.5g (0.47oz)

Restoral Topical analgesic ointment - Outer label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Restoral box 54.1g (1)Restoral box 54.1g (1)Restoral box 54.1g (2)Restoral box 54.1g (2)Restoral 13.5g boxRestoral 13.5g boxRestoral Drug Facts boxRestoral Drug Facts box

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69204-023RESTORAL (MENTHOL) OINTMENT [NATURES FORMULAE HEALTH PRODUCTS LTD.]2Legacy NDC20181015_781e4746-4215-851a-e053-2a91aa0a42ca.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69204-02369204-023-01, 69204-023-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
471f4e23-e22f-6d66-e063-6394a90ae124781e4746-4215-851a-e053-2a91aa0a42ca2025-12-29WarningsExact identifier
spl set id: 781e4746-4215-851a-e053-2a91aa0a42ca

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.