Label: BEE BRAND MEDICATED- menthol and camphor oil

  • NDC Code(s): 66525-056-01, 66525-056-02
  • Packager: PT. TAWON JAYA MAKASSAR
  • 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 June 30, 2021

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  • ACTIVE INGREDIENT

    Active ingredients
    Menthol 2.2%
    Camphor 4%

  • PURPOSE

    Purpose
    External analgesic
    External analgesic

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of minor aches and pains of muscles and joints due to:
    ■ simple backache
    ■ arthritis
    ■ strains
    ■ bruises
    ■ sprains

  • WARNINGS

    Warnings
    For external use only

  • DO NOT USE

    Do not use
    ■ on wounds
    ■ on irritated or damaged skin
    ■ if excessive irritation develops
    ■ over extensive parts of the body
    ■ if you are allergic to any ingredients in this product

  • WHEN USING

    When using this product 

    ■ avoid contact with the eyes or mucous membranes
    
■ do not bandage tightly

  • STOP USE

    Stop use and ask a doctor if
    ■ condition worsens
    
■ symptoms clear up and occur again within a few days
    ■ symptoms persist for more than 7 days

    ■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

    ■ when using for pain of arthritis if:
        ■ in conditions affecting children under 12 years of age
        ■ redness is present
        ■ pain persists for more than 10 days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ Adults and children 2 years of age and older: Apply to affected area with cotton not more than 3 to 4 times daily.

    ■ Children under 2 years of age: Do not use, consult a doctor.

  • STORAGE AND HANDLING

    Other information
    ■ keep container tightly closed

    ■ store protected from light at 15 to 30 C (59 to 86 F)

  • INACTIVE INGREDIENT

    Inactive ingredients
    Achyranthes root, boesenbergia rotunda root, burpleurum falcatum root, cajuput oil, ceylon citronella root, cinnamomum culilawan leaf oil, coconut oil, garlic bulb, ginger root, greater galangal root, hance pepper aerial parts, onion bulb, pepper root, pubescent angelica root, Saigon cinnamon, turmeric root, turpentine oil, and West Indian lemongrass oil.

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
    ■ you may also report serious side effects to this phone number

  • PRINCIPAL DISPLAY PANEL

    BEE BRAND MEDICATED OIL

    NDC 66525-056-01

    EXTERNAL ANALGESIC

    3 FL OZ (90 mL)
    IMAGE OF BOX

  • PRINCIPAL DISPLAY PANEL

    BEE BRAND MEDICATED OIL

    NDC 66525-056-02

    EXTERNAL ANALGESIC

    2 FL OZ (60 mL)

    IMAGE OF BOX

  • INGREDIENTS AND APPEARANCE
    BEE BRAND MEDICATED 
    menthol and camphor oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66525-056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.2 mg  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACHYRANTHES BIDENTATA ROOT (UNII: 5QIU26R6P1)  
    BOESENBERGIA ROTUNDA ROOT (UNII: J7TKP1SS3G)  
    BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)  
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    CYMBOPOGON NARDUS WHOLE (UNII: A9TR1GFH5L)  
    CINNAMOMUM CULILABAN LEAF OIL (UNII: HAG3U9ZKA6)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARLIC (UNII: V1V998DC17)  
    GINGER (UNII: C5529G5JPQ)  
    GREATER GALANGAL (UNII: 7Y64R856MB)  
    PIPER HANCEI TOP (UNII: AMU868N7QW)  
    ONION (UNII: 492225Q21H)  
    PIPER NIGRUM WHOLE (UNII: 49L10LI8DN)  
    ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)  
    CINNAMOMUM LOUREIROI WHOLE (UNII: 7N878U293P)  
    TURMERIC (UNII: 856YO1Z64F)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66525-056-011 in 1 BOX06/03/2021
    190 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC:66525-056-021 in 1 BOX06/30/2021
    260 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/03/2021
    Labeler - PT. TAWON JAYA MAKASSAR (726639268)
    Establishment
    NameAddressID/FEIBusiness Operations
    PT. TAWON JAYA MAKASSAR726639268manufacture(66525-056)
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