Xpect Stopain Clinical Gel
FDA Label NDC 42961-256

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cintas Corporation for the product Xpect Stopain Clinical (NDC 42961-256). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel 42961-256-01

Active Ingredient

Menthol 10.0%

Purpose

Topical Analgesic

Uses

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

simple backache
arthritis
strains
bruises
sprains

Warnings

For external use only. Avoid contact with eyes.

Flammable: Keep away from fire or flame.

Otc - When Using

When using this 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

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

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

Otc - Keep Out Of Reach Of Children

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

Directions

Adults and children 2 years of age and older:

apply directly onto affected area without the need to bandage
repeat if necessary, but do not apply more than 3 to 4 times daily

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

Other Information

Store at room temperature

Inactive Ingredients

acrylic acid/vinyl ester copolymer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, hydroxypropylcellulose, PEG-8 dimethicone, pentylene glycol, peppermint oil, SD alcohol 39C, triethanolamine, water (USP).