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Xpect Stopain Clinical

Xpect Stopain Clinical Maximum Performance Pain Relief

Approved
Approval ID

e911478f-7153-4700-b945-92ec54972f45

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

Cintas Corporation

DUNS: 056481716

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Menthol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42961-257
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Menthol
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 21, 2025
FDA Product Classification

INGREDIENTS (11)

BOSWELLIA SERRATA OILInactive
Code: 5T1XCE6K8K
Classification: IACT
MENTHOLActive
Quantity: 100 mg in 1 mL
Code: L7T10EIP3A
Classification: ACTIB
DIMETHYL SULFONEInactive
Code: 9H4PO4Z4FT
Classification: IACT
EUCALYPTUS OILInactive
Code: 2R04ONI662
Classification: IACT
GLUCOSAMINE SULFATEInactive
Code: 1FW7WLR731
Classification: IACT
GLYCERIN 1,2-DIMETHYL ETHERInactive
Code: 21JG3RIJ74
Classification: IACT
PEG-8 DIMETHICONEInactive
Code: GIA7T764OD
Classification: IACT
PENTYLENE GLYCOLInactive
Code: 50C1307PZG
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/21/2025

Principal Dispay 42961-257-01

Label01

Xpect Stopain Clinical Spray Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/13/2025

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/13/2025

Inactive ingredients

boswellia serrata extract, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerin, PEG-8 dimethicone, pentylene glycol, peppermint oil, SD alcohol 39C, water (USP).

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/13/2025

Questions or comments?

1-877-973-2811

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/13/2025

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/21/2025

Active ingredient

Menthol 10.0%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/13/2025

Purpose

Topical Analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 5/13/2025

Warnings

For external use only. Avoid contact with eyes.

Flammable: Keep away from fire or flame.

Contents under pressure: do not puncture or incinerate. Do not store at temperature above 120°F.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/13/2025

When using the product

  • use only as directed
  • do not bandage tightly or use a heating pad
  • do not apply to wounds or damaged skin

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/13/2025

Stop use and ask a doctor if

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • excessive irritation of the skin develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 5/13/2025

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/13/2025

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/13/2025

Directions

Adults and children 2 years of age and older:

  • apply directly onto affected area, not more than 3 to 4 times daily
  • wash hands after use

Children under 2 years of age: do not use, consult a doctor

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/13/2025

Other information

  • Store at room temperature

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Xpect Stopain Clinical - FDA Drug Approval Details