FDA.reportPublic FDA data

Pain Crush

Manufacturer
Genexa Inc.
Effective date
2019-08-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:00:03

Label at a glance#

ProductPain Crush
Active ingredientMENTHOL
Label structure16 sections

Storage and handling

Other information store between 20 to 25°C (68 to 77°F) close cap tightly after use see bottom of bottle for Lot No. and Exp. Date.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient +

Menthol 7%

OTC - PURPOSE SECTION

Purpose

Topical analgesic

INDICATIONS & USAGE SECTION

Uses temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

WARNINGS SECTION

Warnings

For external use only.

Flammable. Keep away from fire or flame.

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damaged skin
  • on a child under 12 years of age with arthritis-like conditions

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have redness over the affected area.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly or use with a heating pad

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • excessive skin irritation occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • shake well before each use
  • adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

STORAGE AND HANDLING SECTION

Other information

  • store between 20 to 25°C (68 to 77°F)
  • close cap tightly after use
  • see bottom of bottle for Lot No. and Exp. Date.

INACTIVE INGREDIENT SECTION

Inactive ingredients

organic aloe vera leaf juice, organic ethyl alcohol, organic glycerin, organic licorice root extract, organic peppermint oil, purified water (aqua), xanthan gum

SPL UNCLASSIFIED SECTION

+Certified Organic, free of parabens, dyes, petroleum and genetically modified organisms

Distributed by: Genexa Inc., Beverly Hills, CA 90211 www.genexa.com

Questions? 1-855-GENEXA-1

Certified Organic by SCS Global Services

MADE IN THE USA WITH GLOBALLY SOURCED INGREDIENTS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genexa®

COLD THERAPY PAIN RELIEF ROLL ON

PAIN CRUSH™

Menthol / Topical Analgesic

3 FL OZ (89 mL)

Back Pain + Arthritis / Sore Muscles + Joints / Shoulder + Leg Pain

USDA ORGANIC

NON GMO Project VERIFIED

FREE OF DYES & PARABENS

NDC 69676-0004-6

Pain Crush_label_20190304Pain Crush_label_20190304

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311509menthol 7 % Topical GelPSN2
311509menthol 0.07 MG/MG Topical GelSCD2
311509menthol 7 % Topical GelSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130857630006625GTIN-13: 0857630006625
EAN-13: 0857630006625
GTIN-12: 857630006625
UPC-A: 857630006625
GTIN storage (14 digits): 00857630006625		Pain Crush_label_20190314.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0004-62025-01-30C16284748780-12cef2736-7a3e-d83d-e063-dadaa90ab31fPain Crush

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0004-6Pain Crush89 mL in 1 BOTTLE, WITH APPLICATORGEL892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0004PAIN CRUSH (MENTHOL) GEL [GENEXA INC.]2Legacy NDC, 1 package rows20190814_6e8dd8bb-7204-34ca-e053-2a91aa0a9ef3.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-000469676-0004-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
ALCOHOL3K9958V90MIACT
LICORICE61ZBX54883IACT
PEPPERMINT OILAV092KU4JHIACT

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
90140c05-4b61-f124-e053-2995a90a3a7f6e8dd8bb-7204-34ca-e053-2a91aa0a9ef32019-08-14WarningsExact identifier
spl id: 90140c05-4b61-f124-e053-2995a90a3a7f
spl set id: 6e8dd8bb-7204-34ca-e053-2a91aa0a9ef3

Reported adverse events (FAERS/openFDA)#

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