RESTORAL- menthol ointment

Restoral by

Drug Labeling and Warnings

Restoral by is a Otc medication manufactured, distributed, or labeled by Saje Natural Business Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 0.2%

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 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)

Restoral Topical analgesic ointment - Outer label

INGREDIENTS AND APPEARANCE

RESTORAL 
menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70983-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
LOBELIA INFLATA LEAF (UNII: 7QFT17RLRG)
OLIVE OIL (UNII: 6UYK2W1W1E)
COMFREY ROOT (UNII: M9VVZ08EKQ)
PEPPERMINT OIL (UNII: AV092KU4JH)
ST. JOHN'S WORT (UNII: UFH8805FKA)
STELLARIA MEDIA (UNII: 2H03479QVR)
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
YELLOW WAX (UNII: 2ZA36H0S2V)
BERBERIS AQUIFOLIUM ROOT (UNII: 746TB9VNDP)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LARREA TRIDENTATA LEAF (UNII: PK0TXD049P)
TEA TREE OIL (UNII: VIF565UC2G)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
QUERCUS ALBA BARK (UNII: 93LP7Y8EGT)
ROSEMARY (UNII: IJ67X351P9)
WITCH HAZEL (UNII: 101I4J0U34)
AGRIMONIA EUPATORIA LEAF (UNII: 8Z160YZ4AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70983-022-02	13.5 g in 1 CONTAINER; Type 0: Not a Combination Product	09/12/2018
2	NDC: 70983-022-01	1 in 1 BOX	09/12/2018
2		54.1 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/01/2018

Labeler - Saje Natural Business Inc. (203413380)