Bt Pain Relief Spray
FDA Label NDC 82198-0012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Big 5 Nutrition Llc for the product Bt Pain Relief (NDC 82198-0012). 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, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Menthol 10%
Methyl Salicylate 5%
Purpose
External analgesic
Uses
For temporary relief of joint and muscles aches and pains
- sprains and strains
- inflammation
- mild bruises
Warnings
For external use only
- Use only as directed
- Avoid contact with the eyes or mucous membranes
- Do not use on open wounds or irritated or broken skin.
- Discontinue use if skin rash or irritation develops or if condition worsens.
- Consult your doctor before use if you are pregnant or breast feeding.
Directions
Clean and dry application area. Spray treatment directly onto skin and gently rub in if desired. May be used up to 10 times per day in adults and children over age 2.
Other Information
- Store at room temperature
- Shake well before use, close cap tightly after use
- Read all product information before use
Inactive Ingredients
Cinnamomum kanehirae Hayata Essential Oil, Saposhnikoviae Radix, Artemisia Argyi Folium, Moutan Cortex, Cimicifugae Rhizoma, Sophorae Flavescentis Radix, Paeoniae Radix, Rubra Notoginseng Radix et Rhizoma, Carthami Flos, Alcohol.
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