Biotemper
FDA Label NDC 70744-516
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biotemper for the product Biotemper (NDC 70744-516). 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 drug facts, active ingredients, purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
* Please review the disclaimer below.
