Biotemper Foot Cream
FDA Label NDC 71718-222

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 Foot Cream (NDC 71718-222). 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

→ Drug Facts

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Other Information

→ Questions Or Comments?

→ Other

→ Packaging

Drug Facts

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 • bruises • 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 • 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, Carbomer, Frankincense Oil, Green Tea, Hydroxypropyl Cellulose NF, Isopropyl Alcohol, Lavender Oil, Mineral Oil, Polysorbate-60, Preserved Water, Propylene Glycol, Tea Tree Oil, Thymol, Triethanolamine, Vitamin E