Label: BB MEDICATED PAIN RELIEVING OIL oil

  • Category: HUMAN OTC DRUG LABEL

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 November 1, 2014

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredients

    Capsaicin natural extract 0.25 % as capsaicin

    Camphor 3 %

    Menthol 12 %

    Methyl Salicylate 15 %

    Eucalyptus Oil 15 %

  • Purpose

    Capsaicin natural extract ........................................... .Topical Analgesic

    Camphor …………………………………………….........Topical Analgesic

    Menthol ....................................................................... Topical Analgesic

    Methyl Salicylate ..........................................................Topical Analgesic

    Eucalyptus Oil ..............................................................Topical Analgesic

  • Uses

    Apply on Skin only; for temporary relief of minor aches & pains of muscles & joints associated with sports and/or aging symptoms:

    ■ Simple backache ■ arthritis ■ strains ■ bruises ■ sprains

  • Warnings

    Keep out reach of children

    If swallowed, get medical help or contact poison control center immediately.

    Do not use

    ■ on wounds or damaged skin.

    ■ with a heating pad

    ■ with, or at the same time as, other external analgesic products.

    ■ if you are allergic to any ingredients of this product.

    When using this product:

    ■ do not use otherwise than as directed.

    ■ avoid contact with eyes, mucous membranes or rashes.

    Stop use and consult a doctor for:

    ■ rash, itching or excessive skin irritation develops.

    ■ conditions worsen.

    ■ symptoms persist for more than7 days.

    ■ symptoms clear up and occur again within a few days.

    If swallowed, get medical help or contact poison control center immediately.

  • Directions and Allergy alert:

    If prone to allergic reaction from aspirin or salicylates, consult a doctor before use

    Adults and children12 years of age and over:

    ■ clean and dry affected area.

    ■ apply to affected area not more than 2 times a day.

    Children under 12 years of age:

    ■ consult a doctor

  • Flammable and Safe Handling

    • keep away from fire or flame
    • do not use where ignition sparks happens
    • do not use in a confined space
    • do not incinerate or heat the bottle
    • do not expose bottle to temeprature exceeding 120 degree F (48 degree C)
  • Do NOT use:

    • on wounds or damaged skins.
    • with a heating pad.
    • if you are allergic to any ingredients of this product
  • When using this product:

    • do not use otherwise than directed to.
    • avoid contact with the eyes, mucous membranes or rashes.
    • do not bandage tightly.
    • do not use on open wounds
  • Stop use and ask a doctor if any of the following happens:

    • rash, itching or excessive skin irritation develops
    • conditions worsen
    • symptoms persist for more than 7 days
    • symptoms clear up and return again within a few days
  • Pregancy or Breast Feeding.

    If you are pregnant or breastfeeding, consult with your physician or a healthcare provider before use.

  • Keep out of reach of children.

    Warnings

    If swallowed, get medical help or contact poison control center immediately.

  • Children under 12 years of age:

    ■ consult a doctor

  • Inactive Ingredients

    Purified water, Ethanol, Cetyl alcohol, Polysorbate 80, Sorbitan monolaurate, Isopropyl myristate.

  • Other Information

    ■ Due to its unique formulation, the solution can turn into different levels of white translucent, milky cloudiness at warmer temperatures; This is totally normal. Upon returning to cooler temperatures it should regain its typical transparency state.

    ■ Avoid storing product in direct sunlight.

    ■ Protect product from excessive moisture.

  • Principle Display Panel-Extra Strength-Capsaicin 0.25/100

    NDC#61079-025-13

    bB Medicated Oil Pain Reliever

    Extra Strength

    0.5 FL. OZ. (13 mL)

    bB BioChem Laboratories, Inc.

    Distributed by

    bB BioChem Laboratories, Inc.

    Santa Ana, CA 92705

    bB BioChemUSA.com

    Extra Strength Capsaicin 0.25/100

    Carton-Extra Strenght- Capsaicin 0.25/100

  • Directions

    Adults and children12 years of age and over:

    • clean and dry affected area.
    • apply to affected area not more than 2 times a day.

    Children under 12 years of age:

    • consult a doctor
  • Principle Display Panel-Sensitive Strength-Capsaicin 0.14/100

    NDC#61079-014-13

    bB Medicated Oil Pain Reliever

    Sensitive Strength-Capsaicin 0.14/100

    0.5 FL. OZ. (13 mL)

    bB BioChem Laboratories, Inc.

    Distributed by

    bB BioChemLaboratories, Inc.

    Santa Ana, CA 92705

    bBBioChemUSA.com

    Sensitive Strenght-Capsaicin 0.14/100

    Sensitive Strenght-Capsaicin 0.14/100

  • INGREDIENTS AND APPEARANCE
    BB MEDICATED PAIN RELIEVING OIL 
    bb medicated pain relieving oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61079-025
    Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3 g  in 100 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL12 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL15 g  in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN) 3 g  in 100 g
    POLYSORBATE 80 (UNII: 6OZP39ZG8H) 11 g  in 100 g
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) 7 g  in 100 g
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 27 g  in 100 g
    ALCOHOL (UNII: 3K9958V90M) 3 g  in 100 g
    WATER (UNII: 059QF0KO0R) 4 g  in 100 g
    Product Characteristics
    Coloryellow (SLIGHT YELLOW COLORATION) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61079-025-1313 g in 1 BOTTLE, GLASS11/01/2014
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2014
    BB MEDICATED PAIN RELIEVING OIL 
    bb medicated pain relieving oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61079-014
    Route of AdministrationPERCUTANEOUS, TOPICAL, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL15 g  in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.14 g  in 100 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN) 3 g  in 100 g
    POLYSORBATE 80 (UNII: 6OZP39ZG8H) 11 g  in 100 g
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) 7 g  in 100 g
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 27 g  in 100 g
    ALCOHOL (UNII: 3K9958V90M) 3 g  in 100 g
    WATER (UNII: 059QF0KO0R) 4 g  in 100 g
    Product Characteristics
    Coloryellow (TRANSPARENT SLIGHT YELLOW COLORATION) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61079-014-1313 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product11/01/2014
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2014
    Labeler - BB BIOCHEM LABORATORIES, INC. (053979073)