Dr. Blue
FDA Label NDC 10578-035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Indiana Botanic Gardens for the product Dr. Blue (NDC 10578-035). 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, when using this product, stop use and ask a doctor if, 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
Active Ingredient
Menthol 4.6%
Purpose
topical analgesic gel
Uses
■ temporary relief of minor aches and pains of muscles & joints associated with
simple backache, arthritis, bruises and sprains ■ provides cooling pain relief
Warnings
For external use only
When Using This Product
■ Do not heat ■ Do not microwave ■ Do not use near open flame ■ Do not add to hot
water or any container when heating water. May cause splattering and result in burns. ■ Avoid
contact with eyes ■ Do not apply to wounds or damaged skin ■ Do not bandage tightly
Stop Use And Ask A Doctor If
condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ See the important warnings under "when using this product"
■ Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
■ Children under 2 years of age: consult physician.
Other Information:
Use only if seal is unbroken.
Inactive Ingredients
Aloe Vera Concentrate, Carbopol-940, Emu Oil, FD&C Blue #1, Glucosamine Sulfate, Glycerin, Green tea Fragrance, Imidazolidinyl Urea, MSM Powder, Propylene Glycol, SDA Alcohol 39B, Triethanolamine, Water
Questions?
1-800-644-8327
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