1. Home
  2. Labeler Index
  3. Universal Distribution Center Llc
  4. 52000-422
  5. Label Information: Cold And Hot Medicated

FDA Label for Cold And Hot Medicated

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. PACKAGING

Cold And Hot Medicated 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.

Drug Facts




Active Ingredient



Menthol 5%


Purpose



Topical Analgesic


Uses



Temporarily relieve minor pain associated with:
• arthritis • simple backache • muscle strains • bursitis • tendonitis • strains • bruises • cramps


Warnings



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 membranes • 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 • skin irritation develops

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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



Adults and Children 12 years of age and older:

  • Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch
  • Should be used up to 8 hours
  • Should be used no more than 3 to 4 times daily
  • Children under 12 years of age: Consult a doctor.

Other Information



  • store at room temperature 68° to 77°F (20° to 25°C)

Inactive Ingredients



Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80


Packaging



image description - 520000 422

image description - 520000 422


* Please review the disclaimer below.