Active Ingredient
Menthol 4.6%
Dr. Blue Painzaway Pain Relieving Roll-on Lotion
FDA Label NDC 10578-136
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 Painzaway Pain Relieving Roll-on (NDC 10578-136). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
topical analgesic
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 a physician.
Other Information:
Use only if seal is unbroken.
Inactive Ingredients
alcohol denat., aloe barbadensis leaf juice, aminomethyl propanol, aqua / water / eau, citric acid, dimethyl sulfone, emu oil, ethylhexylglycerin, FD&C Blue No. 1, glucosamine sulfate, glycerin, potassium sorbate, propylene glycol, raspberry ketone, rosa canina (rosehip) seed oil, sclerotium gum, sodium benzoate, t-butyl alcohol, tocopherol.
Questions?
1-800-644-8327
Other
MANUFACTURED BY
INDIANA BOTANIC GARDENS, INC.
3401 W. 37TH AVE., HOBART, IN 46342
Website: BotanicChoice.com
C-125423
Package Label.Principal Display Panel
Fast Acting
Dr. Blue PainZaway Pain Relieving Roll-On
4.6% Menthol Lotion
Cooling Relief
Net Wt. 3 oz. (85 g).
Product Label (Blun 125423)
* Please review the disclaimer below.
