CMC PAIN RELIEVING- .alpha.,.alpha.-dibromo-d-camphor, menthol, unspecified form, and capsaicin patch

CMC Pain Relieving by

Drug Labeling and Warnings

CMC Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Unexo Life Sciences, Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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 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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 6 Pouch Box

NDC: 71391-125-06

UNEXO's
PAIN RELIEVING
HOT PATCH

External Analgesic

Penetrating pain relief for:

• Back Aches
• Muscles
• Arthritis

6
Adhesive Plaster Patches
4.72 in x 7.07 in (12 cm x 18 cm)

INGREDIENTS AND APPEARANCE

CMC PAIN RELIEVING 
.alpha.,.alpha.-dibromo-d-camphor, menthol, unspecified form, and capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71391-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR (UNII: F89Z8SAG3O) (.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR - UNII:F89Z8SAG3O)	.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR	129.6 mg
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	54 mg
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	1.08 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71391-125-01	1 in 1 POUCH; Type 0: Not a Combination Product	06/01/2020
2	NDC: 71391-125-06	6 in 1 BOX	06/01/2020
2		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2020

Labeler - Unexo Life Sciences, Private Limited (872260479)

Establishment
Name	Address	ID/FEI	Business Operations
Unexo Life Sciences, Private Limited		872260479	MANUFACTURE(71391-125)