Label: EXTRA STRENGTH BALM- capsicum and menthol ointment

  • NDC Code(s): 70983-027-01
  • 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


    Capsicum (from Capsicum Frutescens fruit extract) 5%
    Menthol 2.5%

  • PURPOSE

    External analgesic (counterirritant)

  • INDICATIONS & USAGE

    For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains. Provides warming pain relief.

  • WARNINGS

    For external use only.

  • WHEN USING

    Avoid contact with the eyes.

  • PREGNANCY OR BREAST FEEDING

    Do not use • while pregnant or breastfeeding.

  • DO NOT USE

    Do not apply to • wounds • damaged skin • bandage tightly • with external heat. This may result in skin irritation or skin burn.

  • STOP USE

    Stop use and ask a doctor if • condition worsens, • if symptoms persist for more than 7 days • clear up and reoccur within a few days.

  • DOSAGE & ADMINISTRATION

    Adults: Apply a thin layer to affected area not more than 3-4 times daily, massaging well into skin. Wash hands well after use. Patch test recommended prior to use. Spatula recommended to reduce contact with the product. Do not inhale directly–keep lid on product when not in use.

  • STORAGE AND HANDLING

    Store in a cool, dark place.

  • INACTIVE INGREDIENT

    Beeswax, butyrospermum parkii (shea) butter, calendula officinalis flower extract, capryloyl glycerin, cinnamomum zeylanicum (cinnamon) leaf oil, cocos nucifera (coconut) oil, diheptyl succinate, elettaria cardamomum (cardamom) seed oil, eugenia caryophyllus (clove) bud oil, glycine soja (soybean) oil, olea europaea (olive) fruit oil, prunus amygdalus dulcis (sweet almond) oil, rosmarinus officinalis (rosemary) extract, rosmarinus officinalis (rosemary) leaf oil, rubus idaeus (raspberry) seed oil, sebacic acid copolymer, simmondsia chinensis (jojoba) seed oil, squalane, theobroma cacao (cocoa) seed butter, tocopherol, zingiber officinale (ginger) root oil

  • OTHER SAFETY INFORMATION

    Important: Read all product information before using. Keep this package for full information.

    Do not use if security seal is broken or missing.

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

    made in Canada


    Questions? Call 1-877-ASK-SAJE


    I'm made from recycled paper
    please recycle where possible

  • DESCRIPTION

    Extra Strength Balm

    Warming pain relief ointment

    0.9 fl oz (25 g)

  • KEEP OUT OF REACH OF CHILDREN

  • Extra Strength Balm - outer label

    Extra Strength Balm - outer label

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH BALM 
    capsicum and menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70983-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2258.75 mg  in 1 g
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM5000 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    SQUALENE (UNII: 7QWM220FJH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ROSEMARY (UNII: IJ67X351P9)  
    APIS MELLIFERA (UNII: 7S82P3R43Z)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CARDAMOM OIL (UNII: JM0KJ091HZ)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    CLOVE OIL (UNII: 578389D6D0)  
    CINNAMON LEAF OIL (UNII: S92U8SQ71V)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70983-027-011 in 1 BOX02/24/2023
    125 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/18/2023
    Labeler - Saje Natural Business Inc (080465432)
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