Willow Balm

Manufacturer
I Woke Up Well Distributing Inc
Effective date
2018-01-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:03

Label at a glance#

ProductWillow Balm
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness

Dosage and administration

Apply the product directly to the affected area. Product may be used as necessary, but should not be used more than four times daily.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 3% Counterirritant

Warnings

WARNINGS SECTION

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.

Uses

INDICATIONS & USAGE SECTION

Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness

Other Ingredients

INACTIVE INGREDIENT SECTION

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

STATEMENT OF IDENTITY SECTION

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

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out Of Reach of Children

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTC - PURPOSE SECTION

Use for the temporary relief of minor aches and muscle pains.

main label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Main LabelMain Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1442261menthol 3 % Topical CreamPSN1
1442261menthol 30 MG/ML Topical CreamSCD1
1442261menthol 3 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71629-035-012021-07-23C16284748780-1c7ccaba7-195f-fd44-e053-dadaa90aa01bWillow Balm Nature's Aspirin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71629-035-01Willow Balm1 g in 1 TUBECREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71629-035WILLOW BALM (TOPICAL PAIN RELIEVER) CREAM [I WOKE UP WELL DISTRIBUTING INC]1Legacy NDC, 1 package rows20181019_62d35ec4-83f0-a19a-e053-2a91aa0a863f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71629-03571629-035-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
62d35ec4-83f1-a19a-e053-2a91aa0a863f62d35ec4-83f0-a19a-e053-2a91aa0a863f2018-01-15WarningsExact identifier
spl id: 62d35ec4-83f1-a19a-e053-2a91aa0a863f
spl set id: 62d35ec4-83f0-a19a-e053-2a91aa0a863f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.