FDA.reportPublic FDA data

Restoral

Manufacturer
Saje Natural Business Inc.
Effective date
2026-01-13
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:33:14

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 Drug facts boxDrug facts box

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

2019 RESTORAL_54.1g_DFB2019 RESTORAL_54.1g_DFBRestoral box 15 mlRestoral box 15 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
418609menthol 0.2 % Topical OintmentPSN9
418609menthol 0.002 MG/MG Topical OintmentSCD9
418609menthol 0.2 % Topical OintmentSY9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-022-01Restoral54.1 g in 1 CONTAINEROINTMENT54.19
70983-022-01Restoral1 in 1 BOXOINTMENT19
70983-022-02Restoral13.5 g in 1 CONTAINEROINTMENT13.59

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70983-02270983-022-02, 70983-022-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MATRICARIA CHAMOMILLA FLOWERING TOP3VNC7T6Z02IACT
LOBELIA INFLATA LEAF7QFT17RLRGIACT
OLIVE OIL6UYK2W1W1EIACT
COMFREY ROOTM9VVZ08EKQIACT
PEPPERMINT OILAV092KU4JHIACT
ST. JOHN'S WORTUFH8805FKAIACT
STELLARIA MEDIA2H03479QVRIACT
TRIFOLIUM PRATENSE FLOWER4JS0838828IACT
MENTHOLL7T10EIP3AACTIB
ALTHAEA OFFICINALIS ROOTTRW2FUF47HIACT
YELLOW WAX2ZA36H0S2VIACT
BERBERIS AQUIFOLIUM ROOT746TB9VNDPIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
EUCALYPTUS OIL2R04ONI662IACT
LARREA TRIDENTATA LEAFPK0TXD049PIACT
TEA TREE OILVIF565UC2GIACT
PROPOLIS WAX6Y8XYV2NOFIACT
QUERCUS ALBA BARK93LP7Y8EGTIACT
ROSEMARYIJ67X351P9IACT
WITCH HAZEL101I4J0U34IACT
AGRIMONIA EUPATORIA LEAF8Z160YZ4APIACT

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
RestoralMENTHOLSaje Natural Business Inc.5b6176c1-9ed9-1950-e053-2a91aa0a434e2026-01-13WarningsExact identifier
ndc (package): 70983-022-02
ndc (package): 70983-022-01
ndc (product): 70983-022
ndc11 (package): 70983002202
ndc11 (package): 70983002201
spl id: 485269a3-5a54-ae1e-e063-6294a90ae1de
spl set id: 5b6176c1-9ed9-1950-e053-2a91aa0a434e

Reported adverse events (FAERS/openFDA)#

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