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NDC 71391-0124-18 Menthol 6.5% 910 mg/1 Details

Menthol 6.5% 910 mg/1

Menthol 6.5% is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Unexo Life Sciences, Private Limited. The primary component is MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	71391-0124
Product ID	71391-124_0fd378ac-a5dc-4688-bade-f08cf3152295
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Menthol 6.5%
Proprietary Name Suffix	n/a
Non-Proprietary Name	menthol, unspecified form
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	910
Active Ingredient Units	mg/1
Substance Name	MENTHOL, UNSPECIFIED FORM
Labeler Name	Unexo Life Sciences, Private Limited
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71391-0124-18 (71391012418)

Pricing Information	N/A
NDC Package Code	71391-124-18
Billing NDC	71391012418
Package	18 POUCH in 1 BOX (71391-124-18) / 1 PATCH in 1 POUCH
Marketing Start Date	2020-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f8843dad-5409-4f51-8437-872f4d7e42f1 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
menthol, unspecified form (UNII: L7T10EIP3A) (menthol, unspecified form - UNII:L7T10EIP3A)	menthol, unspecified form	910 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/01/2020

Labeler - Unexo Life Sciences, Private Limited (872260479)

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

Revised: 1/2022

Document Id: 0fd378ac-a5dc-4688-bade-f08cf3152295

Set id: f8843dad-5409-4f51-8437-872f4d7e42f1

Version: 2

Effective Time: 20220118

Search by Drug Name or NDC

NDC 71391-0124-18 Menthol 6.5% 910 mg/1 Details

Menthol 6.5% 910 mg/1

Product Information

Package

Package Images

NDC 71391-0124-18 (71391012418)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL f8843dad-5409-4f51-8437-872f4d7e42f1 Details

SPL UNCLASSIFIED SECTION

Active Ingredient

Uses

Warnings

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

Directions

Other Information

Inactive Ingredients

Questions

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 1 Patch Pouch

INGREDIENTS AND APPEARANCE

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