MENTHOL 6.5%- menthol, unspecified form patch

Menthol 6.5% by

Drug Labeling and Warnings

Menthol 6.5% 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 6.5% - 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

Other Information

• Store at room temperature below 80°F (27°C)

Inactive Ingredients

carboxymethylcellulose sodium, camphor, DMDM hydantoin, dihydroxyl aluminium aminoacetate, emulsifying wax, edetate disodium, glycerin, polysorbate 20, polyvinyl alcohol, polyvinylpyrrolidone, sodium polyacrylate, tartaric acid, titanium dioxide, water

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 - 1 Patch Pouch

Lasts Up to 8 Hours!

MENTHOL 6.5%
PATCH

ULTRA
STRENGTH

Pain Relief
PATCH
6.5%
Menthol

For Shoulders, Arms,
Neck and Legs

Relieves Sore Muscles & Arthritis Pain

• Deep Penetrating. No Mess
• Comfortable, Breathable & Stays on Securely

1 Large Medicated Patch 5 ½ x 4 in (14 x 10 cm)

INGREDIENTS AND APPEARANCE

MENTHOL 6.5% 
menthol, unspecified form patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71391-124
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	910 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
DMDM hydantoin (UNII: BYR0546TOW)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
WHITE WAX (UNII: 7G1J5DA97F)
Edetate Sodium (UNII: MP1J8420LU)
Glycerin (UNII: PDC6A3C0OX)
Polysorbate 20 (UNII: 7T1F30V5YH)
Polyvinyl Alcohol, Unspecified (UNII: 532B59J990)
POVIDONE K60 (UNII: SZR7Z3Q2YH)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
Tartaric acid (UNII: W4888I119H)
Titanium dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71391-124-18	18 in 1 BOX	04/01/2020
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 71391-124-36	36 in 1 BOX	04/01/2020
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	04/01/2020

Labeler - Unexo Life Sciences, Private Limited (872260479)

Establishment
Name	Address	ID/FEI	Business Operations
Unexo Life Sciences, Private Limited		872260479	MANUFACTURE(71391-124)