FDA Label for Bb Medicated Pain Relieving Oil
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- DIRECTIONS AND ALLERGY ALERT:
- FLAMMABLE AND SAFE HANDLING
- DO NOT USE:
- WHEN USING THIS PRODUCT:
- STOP USE AND ASK A DOCTOR IF ANY OF THE FOLLOWING HAPPENS:
- PREGANCY OR BREAST FEEDING.
- KEEP OUT OF REACH OF CHILDREN.
- CHILDREN UNDER 12 YEARS OF AGE:
- INACTIVE INGREDIENTS
- OTHER INFORMATION
- PRINCIPLE DISPLAY PANEL-EXTRA STRENGTH-CAPSAICIN 0.25/100
- DIRECTIONS
- PRINCIPLE DISPLAY PANEL-SENSITIVE STRENGTH-CAPSAICIN 0.14/100
Bb Medicated Pain Relieving Oil Product Label
The following document was submitted to the FDA by the labeler of this product Bb Biochem Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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.
- consult a doctor
Children under 12 years of age:
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
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