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  5. Label Information: Pain Relief Hot Patch

FDA Label for Pain Relief Hot Patch

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS (IN EACH GRAM)
    3. PURPOSE
    4. USES
    5. WARNINGS:
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. PACKAGING

Pain Relief Hot Patch 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 Ingredients (In Each Gram)



Menthol 30 mg

Capsaicin 0.83 mg


Purpose



Topical Analgesic


Uses



Temporarily relieves minor pain associated with:

  • arthritis • simple backache • bursitis • tendonitis • muscle 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.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.


Directions



Adults and Children 12 years of age and older:

• Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions

• Apply to affected area not more than 3 to 4 times a daily

Children under 12 years of age: DO NOT use without consulting a doctor.


Other Information



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


Inactive Ingredients



glycerin, sodium polyacrylate, aluminum glycinate, kaolin, methylparaben, propylparaben, alcohol, titanium dioxide, tartaric acid, sorbitan monooleate, polysorbate 80, purified water


Packaging



Hotpatch - 82634nwlb

Hotpatch - 82634nwlb


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