FDA Label for Cmc Pain Relieving

View Indications, Usage & Precautions

Cmc Pain Relieving Product Label

The following document was submitted to the FDA by the labeler of this product Unexo Life Sciences, Private Limited. 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.

Other



Drug Facts

Manufactured By:
UNEXO LIFE SCIENCES PVT. LTD.
B-16. Sector 4, Bawana Industrial Area,
Delhi – 110039 (INDIA)


Otc - Purpose



Active Ingredient
Camphor 3%External Analgesic
Menthol 1.25%External Analgesic
Capsaicin 0.025%External Analgesic

Uses



For temporary relief of minor aches and pains of muscles and joints associated with:

  • Simple backaches
  • Arthritis
  • Strains
  • Sprains

Warnings



FOR EXTERNAL USE ONLY. Avoid contact with eyes.


Do Not Use



  • On wounds or damaged skin
  • With a bandage or heating pad
  • On sensitive skin
  • if allergic to any ingredient in this product

Stop Use And Ask A Doctor If



  • Condition worsens
  • symptoms persist for more than 7 days
  • clear up and occur again within a few days
  • redness is present

Otc - Pregnancy Or Breast Feeding



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: apply to the affected area not more than 3 to 4 times daily
  • Children under 12 years of age consult a doctor
  • clean and dry affected area
  • remove patch from film
  • apply sticky side of patch to affected area
  • use one patch at a time
  • leave patch on affected area for up to 8 hours at a time

Other Information



  • Store at room temperature 59-86°F (15-30°C)
  • Do not store in direct sunlight or expose to excessive heat
  • TAMPER EVIDENT: Do not use if packet containing the patch is torn or broken


Inactive Ingredients



Adhesive plaster


Questions



Call +91 9212228401


Principal Display Panel - 6 Pouch Box



NDC: 71391-125-06

UNEXO's
PAIN RELIEVING
HOT PATCH

External Analgesic

Penetrating pain relief for:

* Please review the disclaimer below.