Cold And Hot Pain Relief Sleeve
FDA Label NDC 67510-0085

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Cold And Hot Pain Relief Sleeve (NDC 67510-0085). 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, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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

Menthol 16%

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with arthritis, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.

Warnings

For external use only

When Using This Product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membrane
  • do not apply to wounds or damaged skin

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
  • redness is present
  • irritation develops

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years

  • Clean and dry affected area.
  • Cut open pouch and remove Sleeve.
  • Remove the clear plastic insert.
  • Pull Sleeve onto knee, large ankle or elbow.
  • Medication is on the colored section of the Sleeve, so the colored section should be placed on the affected area.
  • Pull Sleeve over itself to make medicine touch directly on your skin.
  • Apply one Sleeve to affected area.
  • Repeat as necessary , but no more than 4 times a day.
  • Sleeve should fit snug, but not tight.
    • Children 12 years or younger: ask a doctor

Inactive Ingredients

Glycerin, Hydroxyethylcellulose, Isopropyl Alcohol, Polysorbate 80, Methylparaben, Propylparaben, Purified Water

Package Label

Image Of Carton Label (Sleevelarge.carton)

Image Of Carton Label (Sleevelarge.carton)

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