FDA.reportPublic FDA data

Dr. Blue PainZaway Pain Relieving Roll-On

Manufacturer
Indiana Botanic Gardens
Effective date
2026-04-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:58

Label at a glance#

ProductDr. Blue PainZaway Pain Relieving Roll-On
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 a 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 a physician.

Other Information:

SPL UNCLASSIFIED SECTION

Use only if seal is unbroken.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

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

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 LabelProduct Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2740415menthol 4.6 % Topical LotionPSN1
2740415menthol 46 MG/ML Topical LotionSCD1
2740415menthol 4.6 % Topical LotionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130310578136033GTIN-13: 0310578136033
EAN-13: 0310578136033
GTIN-12: 310578136033
UPC-A: 310578136033
GTIN storage (14 digits): 00310578136033		BLUN-125423.jpg
Data codeQR Code310578136033|6107969|E202702BLUN-125423.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10578-136-03Dr. Blue PainZaway Pain Relieving Roll-On85 g in 1 CYLINDERLOTION851

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
10578-13610578-136-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
T-BUTYL ALCOHOLMD83SFE959IACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
EMU OIL344821WD61IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MENTHOLL7T10EIP3AACTIB
DIMETHYL SULFONE9H4PO4Z4FTIACT
TOCOPHEROLR0ZB2556P8IACT
AMINOMETHYL PROPANOLLU49E6626QIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID2968PHW8QPIACT
RASPBERRY KETONE7QY1MH15BGIACT
WATER059QF0KO0RIACT
SCLEROTIUM GUM2X51AD1X3TIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ROSA CANINA SEED OILMHT97MG5P8IACT

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
Dr. Blue PainZaway Pain Relieving Roll-OnMENTHOLIndiana Botanic Gardens4ecc8241-5a87-2f45-e063-6294a90aa30a2026-04-06WarningsExact identifier
ndc (package): 10578-136-03
ndc (product): 10578-136
ndc11 (package): 10578013603
spl id: 4ecc8241-5a88-2f45-e063-6294a90aa30a
spl set id: 4ecc8241-5a87-2f45-e063-6294a90aa30a

Reported adverse events (FAERS/openFDA)#

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