Biotemper
FDA Label NDC 71718-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Scientific Solutions Global Llc for the product Biotemper (NDC 71718-111). 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 ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Menthol 10%
Purpose
Topical Analgesic
Uses
For temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • sprains
Warnings
For external use only
Flammable keep away from fire or flame
When using this product • avoid contact with eyes or mucous membranes • do not bandage tightly • do not apply to wound or damaged or irritated skin
Stop use and consult a doctor if • condition worsens • symptoms persist for more than 7 days • clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Directions
• Adults and children 2 years of age and older: Apply to affected area not more than 4 times daily in one direction, not circular. • Children under 2 years of age, consult a physician • Massage not necessary • Shake well before use
Inactive Ingredients
Aloe Vera Oil, Arnica Flower Tincture, Boswellia Powder, Camphor, Frankincense Oil, Green Tea, Hydroxypropyl Cellulose NF, Isopropyl Alcohol, Lavender Oil, Propylene Glycol, Tea Tree Oil, Thymol, Vitamin E
Other Information
• store in a cool and dry place with lid closed tightly
Questions Or Comments?
Call us at: 1(516)543-3376 M-F 9am-6pm EST or E-mail:[email protected]
Packaging
Bio-rollon1 (Label)
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