Bb Medicated Pain Relieving Oil
FDA Label NDC 61079-025

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bb Biochem Laboratories, Inc. for the product Bb Medicated Pain Relieving Oil (NDC 61079-025). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, directions and allergy alert:, flammable and safe handling, do not use:, when using this product:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

* Please review the disclaimer below.