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  5. Label Information: Cvs Cold And Hot

FDA Label for Cvs Cold And Hot

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL - COLD AND HOT PATCH BOX LABEL
    15. PRINCIPAL DISPLAY PANEL - COLD AND HOT PATCH LABEL

Cvs Cold And Hot Product Label

The following document was submitted to the FDA by the labeler of this product Natural Essentials, 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 Ingredients



Lidocaine 4%

Menthol 1%


Purpose



Topical Anesthetic

Topical Analgesic


Use



For the temporary relief of pain.


Warnings



For external use only


Do Not Use



  • more than 1 patch on your body at a time or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

When Using This Product



  • use only as directed. Read and follow all directions and warnings on this carton.
  • Rare cases of serious burns have been reported with products of this type
  • Do not apply to wounds or damaged, broken or irritated skin
  • Do not allow contact with the eyes and mucous membranes
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not use at the same time as other topical analgesics
  • Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug products that can produce serious adverse effects if a child or pet chews or ingests this patch

Stop Use And Ask A Doctor If



  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Otc - Pregnancy Or Breast Feeding



If pregnant or breast feeding ask a physician 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/children 12 years and older
  • clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch for up to 12 hours

Other



Children 12 years or younger: ask a doctor


Other Information



Store at room temperature – do not exceed 86° Fahrenheit, 30° Celsius.


Inactive Ingredients



Benzyl Alcohol, Carboxymethylcellulose Sodium, Dihydroxyaluminium Aminoacetate, Ethanol, Glycerin, Kaolin, Partially Neutralized Polyacrylate, Propylene Glycol, Polysorbate 80, Polyvinyl Pyrrolidone 90, Tartaric Acid , Tetrasodium Edetate, Titanium Dioxide, Urea, Water.


Principal Display Panel - Cold And Hot Patch Box Label



NDC 66902-218-05

MAXIMUM STRENGTH
LIDOCAINE

Cold & Hot
Patch

UP TO
12
HOURS

MEDICATED PAIN RELIEF
WITH MENTHOL

LIDOCAINE 4%

MENTHOL 1%

Principal Display Panel - Cold And Hot Patch Label



CVS
Health™

Compare to the active ingredients
in IcyHot® Lidocaine Patch
Plus Menthol*

NDC 66902-218-05

MAXIMUM STRENGTH
LIDOCAINE

Cold & Hot
Patch

MEDICATED PAIN RELIEF
WITH MENTHOL

LIDOCAINE 4%

MENTHOL 1%

* Please review the disclaimer below.