FDA.reportPublic FDA data

Painzaway Pain Relieving Gel

Manufacturer
Indiana Botanic Gardens
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:37

Label at a glance#

ProductPainzaway Pain Relieving Gel
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

Aloe Vera Concentrate, Carbomer 940, Emu Oil, FD&C Blue #1, Glucosamine Sulfate, Glycerin, Green Tea Fragrance, Imidazolidinyl Urea, MSM Powder, Propylene Glycol, SD 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

PainzAway®

PAIN RELIEVING GEL

NET WT. 5 OZ.

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1549850menthol 4.6 % Topical GelPSN2
1549850menthol 0.046 MG/MG Topical GelSCD2
1549850menthol 4.6 % Topical GelSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10578-135-05Painzaway Pain Relieving Gel57 g in 1 JARGEL572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10578-135PAINZAWAY PAIN RELIEVING GEL (MENTHOL) GEL [INDIANA BOTANIC GARDENS]2Current NDC, Legacy NDC, 1 package rows20241215_dba1d268-ebab-0ac7-e053-2a95a90ad4b6.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10578-13510578-135-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
TEA LEAF OILVC855RRT77IACT
IMIDUREAM629807ATLIACT
WATER059QF0KO0RIACT
CARBOMER 9404Q93RCW27EIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
EMU OIL344821WD61IACT
GLYCERINPDC6A3C0OXIACT

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
Painzaway Pain Relieving GelMENTHOLIndiana Botanic Gardensdba1d268-ebab-0ac7-e053-2a95a90ad4b62024-12-13WarningsExact identifier
ndc (package): 10578-135-05
ndc (product): 10578-135
ndc11 (package): 10578013505
spl id: 2927e7a0-4cb0-3592-e063-6294a90a9fac
spl set id: dba1d268-ebab-0ac7-e053-2a95a90ad4b6

Reported adverse events (FAERS/openFDA)#

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