Avedana Cool Hot Ice Gel
FDA Label NDC 43749-321

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unipack, Inc. for the product Avedana Cool Hot Ice (NDC 43749-321). 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, do not use, ask a doctor before use, when using this product, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Active Ingredients                                                      Purpose

Menthol 2%..................................................External Pain Reliever

Purpose

External Pain Reliever

Uses

Temporarily relief of minor pains of muscles and joints associated with - simple back ache - arthritis - sprains, strains, or bruises

Warnings

Warnings

For external use only.  Avoid contact with eyes

Do Not Use

Do not use - internally - with heating pad or devices - on wounds or damaged skin

Ask A Doctor Before Use

Ask doctor before use if you have sensitive skin

When Using This Product

When using this product - Use only as directed - do not bandage tightly - avoid contact with eyes and mucus membranes

If Pregnant Or Breast-Feeding

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

Keep Out Of Reach Of Children

Keep out of reach of children.  In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

-Adult and children 2 years of age and older.  Clean skin thoroughly.  Apply liberally to affected area no more than 3-4 times daily.  No protective cover needed.

-May be used with ice packs

-May be used with wet or dry bandages, but wrap loosely

-Children under 2 years of age, consult a doctor

Other Information

Other information store between 59o - 86oF (15o - 30oC)

Keep tightly closed

Do not use, pour, spill, or store near heat or open flame

Other Ingredients

Camphor, Carbomer 940, FDC Blue #1, Isopropyl alcohol, Propylene glycol, Purified water, Sodium hydroxide

* Please review the disclaimer below.