Label: RESTORAL- menthol ointment

  • NDC Code(s): 70983-022-01, 70983-022-02
  • Packager: Saje Natural Business Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 5, 2023

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  • 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

    2019 RESTORAL_54.1g_DFB2019 RESTORAL_15ml_DFB2019 RESTORAL_drugfactsbox

  • INGREDIENTS AND APPEARANCE
    RESTORAL 
    menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70983-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70983-022-0213.5 g in 1 CONTAINER; Type 0: Not a Combination Product09/12/2018
    2NDC:70983-022-011 in 1 BOX09/12/2018
    254.1 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/01/2018
    Labeler - Saje Natural Business Inc. (080465432)
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