Label: EXTRA STRENGTH- menthol and methyl salicylate oil

  • NDC Code(s): 69204-027-01
  • Packager: NATURES FORMULAE HEALTH PRODUCTS LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 10, 2022

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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
    1.5 fl oz (45 ml)

  • Extra Strength USA Artwork_Box

    2022-01-03 Extra Strength USA Artwork_Box

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH 
    menthol and methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69204-027
    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:69204-027-011 in 1 BOX05/13/2019
    145 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/13/2019
    Labeler - NATURES FORMULAE HEALTH PRODUCTS LTD. (241385587)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natures Formulae Health Products Ltd.241385587manufacture(69204-027)
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