Otc - Active Ingredient
Active Ingredient
Menthol 4.0% w/w ...... Purpose: Topical Analgesic
Pain Relief Gel-tube Gel
FDA Label NDC 84008-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bullet Point Llc for the product Pain Relief Gel-tube (NDC 84008-003). 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 otc - active ingredient, otc - purpose, warnings, warnings and precautions, indications & usage, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
(Menthol) Topical Analgesic
Warnings
Warnings
For external use only
Warnings And Precautions
Flammable
• Keep away from fire or flame
Indications & Usage
Use
Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains
When using this product
• Avoid contact with 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 a heating pad or device
• Store in a cool, dry place
Stop use if
• Condition worsens or if symptoms persist for more than 7 days, or clear up and recur.
Otc - Ask Doctor
Ask a doctor if
Condition worsens or if symptoms persist for more than 7 days. or clear up and reoccur.
Otc - Pregnancy Or Breast Feeding
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 the Poison Control Center immediately.
Dosage & Administration
Directions
Adults and children 12 years of age and over:
- Rub a thin film over affected areas not more than 4 times daily
- Massage not necessary
Children under 12 years old: Consult physician
Other Safety Information
Other Information
- Avoid storing the product in direct sunlight
- Protect the product from excessive moisture.
Inactive Ingredient
Inactive Ingredients
Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water
Otc - Questions
Questions or Comments
Call +1-888-806-6834
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