Bump And Bruise Reliever
FDA Label NDC 72663-636
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Welly Health Pbc for the product Bump And Bruise Reliever (NDC 72663-636). 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, 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 Ingredient
Menthol 1.5%
Purpose
Pain Relief
Uses
Temporary relief from minor aches and pains of muscles & joints associated with: • backache • strains • bruises • sprains
Warnings
For external use only.
Flammable: Keep away from excessive heat or open flame.
Ask a doctor before use if you have: sensitive skin
When using this product • Avoid contact with the eyes or mucous membranes • 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
If pregnant or breastfeeding: Ask a health professional before use
Directions
• Adults and children 2 years of 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
Other Information
Store in a cool dry place with lid closed tightly
Inactive Ingredients
Acrylamide Sodium Acryloyldimethyl Taurate Copolymer, Aqua, Arnica, Castor Oil, Cetostearyl Alcohol, Glycerin, Isohexadecane, Polysorbate 80,
Sodium Benzoate, Sorbitan Monooleate, Sorbitol
Packaging
Image (72663636 67)
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