FDA Label for Biotemper

View Indications, Usage & Precautions

Biotemper Product Label

The following document was submitted to the FDA by the labeler of this product Biotemper. 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.

Drug Facts




Active Ingredients



Menthol USP 10%.

Camphor USP 2%


Purpose



Topical Analgesic


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children: If ingested, seek medical help and contact a Poison Control Center immediately.


Indications & Usage



Uses : Soothing temporary relief from minor aches and pains associated with • sore muscles • strains • joint discomfort • arthritis • backache • tendonitis


Warnings



Warning: For external use only.

Flammable: Keep away from excessive heat or open flames.

Ask a doctor before using if you have: Sensitive skin If pregnant or breast feeding: Ask a health professional before use.

When using this product: • Avoid contact with eyes or mucous membrane. • Do not apply to wounds or damaged skin. • Do not use with other ointments, creams, sprays or liniments. • Do not apply to irritated skin or if excessive irritation develops. • Do not bandage. • Wash hands after use with cool water • Do not use with heating pad or device.
Stop use and ask a doctor if: Condition worsens or if symptoms persist for more than 7 days or clear up and reoccur.


Dosage & Administration



Directions: Adult and Children 2 years age and older: Rub a thin film over affected areas not more than 4 times daily: Massage not necessary Children under 2 years of age: Consult physician.


Inactive Ingredient



Inactive Ingredients: Aloe Vera Oil, Arnica Flower Tincture, Hydroxypropyl Cellulose NF, Isopropyl Alcohol, Propylene Glycol USP


Storage And Handling



Other information: Store in a cool and dry place with the lid closed tightly.


Other



NO NSAIDS, IBUPROFEN, ASPIRIN OR SALICYLATE

FOR ARTHRITIS/BACK PAIN/ BRUISES/SORE MUSCLES/ SPORTS SPRAINS

Shake well before each use. Apply by rolling in only one direction.

Do not use in a circular motion


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