Active Ingredients
Menthol 3% Counterirritant
Willow Balm
FDA Label NDC 71629-035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by I Woke Up Well Distributing Inc for the product Willow Balm (NDC 71629-035). 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 active ingredients, warnings, uses, other ingredients, contact information, directions, purpose, main label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
WARNINGS for external use only. Use only as directed. Avoid contact
with eyes and mucus membranes. Do not cover with bandage. Do not use on open wounds or damaged skin.
Keep out of reach of Children. Consult physician for children under 12.
Keep Out Of Reach of Children
Uses
Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness
Other Ingredients
BOTANICALS White Willow Bark, Camphor, Eucalyptus Oil, Lavender Oil, Geranium Oil, Helichrysum Gymnocephalum Oil,
Spearment Oil OTHER INGREDIENTS water, mineral oil, cetyp alcohol, stearic acid, stearyl alcohol, cetearyl alcohol,
cetereth, propylene glycol, isopropyl palmtate, almond oil, glycol monostearate, phenoxy ethanol, caprylyl glycol,
jojoba seed oil
Contact Information
For more informatin contact us at: 888-609-4556, or visit www.willowbalm.com Made in the USA I Woke Up Well Distributing, Inc. US Pat. 8765194
Directions
Apply the product directly to the affected area. Product may be used as necessary, but should not be used more than four times daily.
Purpose
Use for the temporary relief of minor aches and muscle pains.
* Please review the disclaimer below.
