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NDC 50488-1040-01 Menthol 40 mg/g Details

Menthol 40 mg/g

Menthol is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Alexso, Inc. The primary component is MENTHOL.

Product Information

NDC	50488-1040
Product ID	50488-1040_d452ca4e-4a2f-410d-9b15-4c87d3904d91
Associated GPIs	90070060003711
GCN Sequence Number	079722
GCN Sequence Number Description	menthol CREAM (G) 4 % TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	46275
HICL Sequence Number	002608
HICL Sequence Number Description	MENTHOL
Brand/Generic	Generic
Proprietary Name	Menthol
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	40
Active Ingredient Units	mg/g
Substance Name	MENTHOL
Labeler Name	Alexso, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 50488-1040-01 (50488104001)

Pricing Information	N/A
NDC Package Code	50488-1040-1
Billing NDC	50488104001
Package	120 g in 1 BOTTLE (50488-1040-1)
Marketing Start Date	2019-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ebfd4e87-3dd4-4db0-a26b-3a11a9811886 Details

SPL UNCLASSIFIED SECTION

Menthol 4% Cream

Alexso, Inc

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Menthol 4% Cream

Drug Facts

Active ingredient

Menthol 4%

Purpose

Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

Warnings

For external use only.

When using this product

Avoid contact with the eyes
Do not use in large quantities, particularly over raw surfaces or blistered areas
Do not apply to wounds or damaged skin
Do not bandage

Stop use and ask a doctor if

allergic reaction occurs
condition worsens or does not improve within 7 days
symptoms clear up and return within a few days
redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years and older	apply externally to the affected area up to 3 to 4 times a day
children under 2 years	ask a doctor

Other information

May be applied under occlusive dressing.
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

Inactive ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isopropyl Alcohol, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine

Menthol 4% Cream

NDC: 50488-1040-1

120 grams

Manufactured for:

Alexso, Inc

Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

NDC 50488-1040-1

Menthol 4% Cream

120 grams

INGREDIENTS AND APPEARANCE

MENTHOL

menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50488-1040
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)
LAURETH-7 (UNII: Z95S6G8201)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50488-1040-1	120 g in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	04/01/2019

Labeler - Alexso, Inc (963338061)

Revised: 4/2019

Document Id: d452ca4e-4a2f-410d-9b15-4c87d3904d91

Set id: ebfd4e87-3dd4-4db0-a26b-3a11a9811886

Version: 2

Effective Time: 20190424