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  5. Label Information: Universal Ice Cold Analgesic

FDA Label for Universal Ice Cold Analgesic

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF THE REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL

Universal Ice Cold Analgesic Product Label

The following document was submitted to the FDA by the labeler of this product Universal Distribution Center Llc. 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 Ingredients



Menthol 1.25%


Purpose



Topical Analgesic


Uses



Temporary relieves  of minor aches and pains in muscles and joints associated with

  • arthritis
  • simple backache
  • strains
  • bruises
  • sports injuries
  • sprains
  • provides cooling penetrating relief


Warnings



For external use only

Do not use

  • with other topical pain relievers
  • with heating pads or heating devices

When Using This Product



  • do not use in or near the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop Use And Ask Doctor If



  • condition worsens
  • symptoms last more than 7 days or clean up and occur again within a few days
  • redness or irritation develops

If Pregnant Or Breast-Feeding,



  • ask a health professional before use

Keep Out Of The Reach Of Children



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


Directions



  • clean affected area before applying product
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Other Information



  • store at controlled room temperature 20 to 25oC (68 to 77oF in a tightly closed container
  • do not use, pour, spill or store near heat or open flame

Inactive Ingredients



Water, Propylene glycol, Isopropyl alcohol, Carbomer, Sodium hydroxide, Benzyl alcohol, Edetate Disodium, Butylated hydroxytoluene, Camphor, Fd&c Blue No. 1


Principal Display Panel



ICE COLD
ANALGESIC GEL
8 FL.OZ (227 GRAM)

PRINCIPAL DISPLAY PANEL - ice cold gel

PRINCIPAL DISPLAY PANEL - ice cold gel





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