Label: EXTRA STRENGTH- menthol and methyl salicylate oil

  • NDC Code(s): 70983-023-02
  • 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 10.5%, Methyl Salicylate 13.4%

  • PURPOSE

    External analgesic (Counterirritant)

  • INDICATIONS & USAGE

    For the temporary relief of minor aches and pains of muscles and joints associated with: • simple back ache • arthritis • strains • bruise • sprains

  • WARNINGS

    For external use only

  • Flammable

    Keep away from fire and flame

  • DO NOT USE

    Do not use on wounds or damaged skin

    Do not bandage tightly

    Do not use if you are allergic to plants of the asteraceae/compositae/daisy family

  • WHEN USING

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

  • STOP USE

    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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product swallowed, get medical help or contact a Poison Control Centre right way.

  • DOSAGE & ADMINISTRATION

    Adults: apply to affected area no more than 3 to 4 times daily.

  • STORAGE AND HANDLING

    Store at room temperature.

  • INACTIVE INGREDIENT

    Anthemis nobilis flower oil, elettaria cardamomum seed oil, kunzea ambigua branch/leaf/twig oil, lavender oil, origanum majorana leaf oil, rosmarinus officinalis (rosemary) leaf oil, syzygium aromaticum bud oil, vitis vinifera (grape) seed oil

  • OTHER SAFETY INFORMATION

    Important: Read all product information before using. Keep this package for full information.
    Do not use if security seal around bottle is broken or missing.
    Questions? Call 1-877-275-7253

    distributed by: saje natural wellness 22 east 5th ave vancouver, bc canada v5t 1g8 saje.com 1-877-ask-saje @sajewellness

  • DESCRIPTION

    Extra Strength
    Pain Relieving Oil Blend
    0.68 fl oz (20 ml)

  • Extra Strength 20 ml

    Extra Strength 20 ml artwork

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH 
    menthol and methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70983-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL94.41 mg  in 1 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE123.74 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
    KUNZEA AMBIGUA WHOLE (UNII: R09L2486DI)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ORIGANUM MAJORANA (UNII: R40XM3HU5X)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    BETULA LENTA BARK (UNII: J689T0DVJQ)  
    ELETTARIA CARDAMOMUM WHOLE (UNII: KH2S76267N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70983-023-0220 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/13/2019
    Labeler - Saje Natural Business Inc. (080465432)
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