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  5. Label Information: Frozen Ice Fast Pain Relief

FDA Label for Frozen Ice Fast Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. INACTIVE INGREDIENT
    3. KEEP OUT OF REACH OF CHILDREN
    4. WARNINGS
    5. INDICATIONS & USAGE
    6. DOSAGE & ADMINISTRATION
    7. PURPOSE
    8. OTHER INFORMATION:

Frozen Ice Fast Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Gadal Laboratories, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Active IngredientsPurpose
Menthol 3.5%Topical Analgesic
Camphor 0.2%Topical Analgesic

Inactive Ingredient



Carbomer, Propylene Glycol, Methylparaben, Isopropyl Alcohol, Triethanolamine, FD&C Blue #1, Purified Water.


Keep Out Of Reach Of Children



KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN


Warnings



For the external use only. Use only as directed.

  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occurs again within a few days, discontinue use of this product and consults a doctor.
  • Avoid contact with eyes.
  • Do not use with other topical products.
  • Do not use with heating device.
  • Do not apply to open wounds or damaged skin.

    • In case of accidental ingestion, seek professional help and contact a Poison Control Center immediately.


Indications & Usage



For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.


Dosage & Administration



Adults and children 12 years of age and older.
Apply to painful muscles and joints.
Gently massage thoroughly into affected area.
Repeat as necessary but no more than 4 times daily


Purpose



Topical Analgesic


Other Information:



Store in cool, dry location at room temperature 59°- 86°F (15° - 30°C) with cao closed tightly. Keep away from excessive heat or open flame.

Manufactured by:

GABAL Laboratories, Inc.

Miami, FL 33186 – (305)382-3288

www.gadallaboratories.com

MADE IN USA


* Please review the disclaimer below.