Cryo10 Topical Analgesic Gel
FDA Label NDC 83549-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Element 26 Llc for the product Cryo10 Topical Analgesic (NDC 83549-000). 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 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.

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

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

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: • roll directly onto affected area without the need to rub, massage or bandage • repeat if necessary, but do not apply more than 4 times daily.

Children 12 years of younger:ask a doctor.

Other Information

  • Store at room temperature

Inactive Ingredients

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

Package Labeling:

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