FDA.reportPublic FDA data

Dr. Blue

Manufacturer
Indiana Botanic Gardens
Effective date
2016-11-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:58

Label at a glance#

ProductDr. Blue
Active ingredientMENTHOL
Label structure13 sections

Indications and uses

■ temporary relief of minor aches and pains of muscles & joints associated with simple backache, arthritis, bruises and sprains ■ provides cooling pain relief

Dosage and administration

■ 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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4.6%

Purpose

OTC - PURPOSE SECTION

topical analgesic

Uses

INDICATIONS & USAGE SECTION

■ temporary relief of minor aches and pains of muscles & joints associated with simple backache, arthritis, bruises and sprains ■ provides cooling pain relief

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

■ 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

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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:

SPL UNCLASSIFIED SECTION

Use only if seal is unbroken.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-644-8327

SPL UNCLASSIFIED SECTION

MANUFACTURED BY

INDIANA BOTANIC GARDENS, INC.

3401 W. 37TH AVE. HOBART, IN 46342

Website: BotanicChoice.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Relieving Gel

Dr. Blue

Bend Free All Day

image of label
image of label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1549850menthol 4.6 % Topical GelPSN1
1549850menthol 0.046 MG/MG Topical GelSCD1
1549850menthol 4.6 % Topical GelSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10578-131-02Dr. Blue57 g in 1 TUBEGEL571
10578-131-05Dr. Blue142 g in 1 JARGEL1421

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10578-131DR. BLUE (MENTHOL) GEL [INDIANA BOTANIC GARDENS]1Current NDC, Legacy NDC, 2 package rows20161111_1b1150bd-e087-4d8f-b0d6-0d935cf6e31e.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10578-13110578-131-02, 10578-131-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
IMIDUREAM629807ATLIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
EMU OIL344821WD61IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
GLYCERINPDC6A3C0OXIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
FD&C BLUE NO. 1H3R47K3TBDIACT

Source Document#

Source XML · Source PDF

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
Dr. BlueMENTHOLIndiana Botanic Gardens1b1150bd-e087-4d8f-b0d6-0d935cf6e31e2016-11-01WarningsExact identifier
ndc (package): 10578-131-05
ndc (package): 10578-131-02
ndc (product): 10578-131
ndc11 (package): 10578013105
ndc11 (package): 10578013102
spl id: 3b057467-ca8c-48c2-99ad-80a012b5f74b
spl set id: 1b1150bd-e087-4d8f-b0d6-0d935cf6e31e

Reported adverse events (FAERS/openFDA)#

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