MENTHOL 5%- menthol, unspecified form patch

Menthol 5% by

Drug Labeling and Warnings

Menthol 5% 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

Menthol 5% - Topical Analgesic

Uses

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

• Simple backache
• Arthritis
• Sprains
• Strains
• Bruises

Warnings

For external use only

Do not use

• On wounds or damaged skin
• With a heating pad

Ask a doctor before use if you have

• Redness over affected area

When using this product

• Avoid contact with eyes and mucous membranes
• Do not bandage tightly

Stop use and ask a doctor if

• Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
• Excessive skin irritation occurs

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 no more than 3 to 4 times daily
• Open pouch & remove patch
• Peel off protective film and apply sticky side to affected area
• Children under 12 years of age consult a doctor

Inactive Ingredients

Adhesive plaster, aloe extract, dl-camphor, purified lanolin, spearmint, titanium dioxide, zinc oxide

Questions

Call 1-215-666-3200

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 1 Patch Pouch

Lasts upto 8 Hours!

MENTHOL 5%
PATCH

XL

Pain Relief
BACK
PATCH
5% Menthol

Relieves Back Pain & Stiffness

Not Messy or Greasy
Comfortable, Breathable & Stays on Securely

1 Extra Large
Medicated Patch
9 x 4 in (22 x 10 cm)

INGREDIENTS AND APPEARANCE

MENTHOL 5% 
menthol, unspecified form patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71391-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	440 mg

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
Camphor (synthetic) (UNII: 5TJD82A1ET)
Lanolin (UNII: 7EV65EAW6H)
Spearmint (UNII: J7I2T6IV1N)
Titanium Dioxide (UNII: 15FIX9V2JP)
Zinc Oxide (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71391-123-18	18 in 1 BOX	03/01/2018
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 71391-123-36	36 in 1 BOX	03/01/2018
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	03/01/2018

Labeler - Unexo Life Sciences, Private Limited (872260479)

Establishment
Name	Address	ID/FEI	Business Operations
Unexo Life Sciences, Private Limited		872260479	MANUFACTURE(71391-123)