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NDC 50488-0410-01 Menthol 10 percent plus Camphor 4 percent 4; 10 g/100g; g/100g Details

Menthol 10 percent plus Camphor 4 percent 4; 10 g/100g; g/100g

Menthol 10 percent plus Camphor 4 percent is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Alexso, Inc. The primary component is CAMPHOR (SYNTHETIC); MENTHOL.

Product Information

NDC	50488-0410
Product ID	50488-0410_97897a7d-04fb-46e0-822f-3c87912f5cb3
Associated GPIs	90809902503720
GCN Sequence Number	080224
GCN Sequence Number Description	menthol/camphor CREAM (G) 10 %-4 % TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	46959
HICL Sequence Number	002600
HICL Sequence Number Description	MENTHOL/CAMPHOR
Brand/Generic	Generic
Proprietary Name	Menthol 10 percent plus Camphor 4 percent
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol and Camphor
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	4; 10
Active Ingredient Units	g/100g; g/100g
Substance Name	CAMPHOR (SYNTHETIC); 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 50488-0410-01 (50488041001)

Pricing Information	N/A
NDC Package Code	50488-0410-1
Billing NDC	50488041001
Package	120 g in 1 BOTTLE (50488-0410-1)
Marketing Start Date	2019-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fbab708f-cec9-417a-aa12-905aa9f460cc Details

SPL UNCLASSIFIED SECTION

Menthol 10% and Camphor 4% Cream

Alexso, Inc

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Menthol 10% and Camphor 4% Cream

Drug Facts

Active ingredient

Purpose

Menthol 10% ……………………………………..………………….…Topical analgesic

Camphor 4% ……………………………………………………………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, Glucosamine Sulfate, Glycerin, Glyceryl Caprylate, 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 10% and Camphor 4% Cream

NDC: 50488-0410-1

120 grams

Manufactured for:

Alexso, Inc

Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

NDC 50488-0410-1

Menthol 10% +

Camphor 4% Cream

120 grams

INGREDIENTS AND APPEARANCE

MENTHOL 10 PERCENT PLUS CAMPHOR 4 PERCENT

menthol and camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50488-0410
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
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)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50488-0410-1	120 g in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	09/01/2019

Labeler - Alexso, Inc (963338061)

Revised: 10/2022

Document Id: 97897a7d-04fb-46e0-822f-3c87912f5cb3

Set id: fbab708f-cec9-417a-aa12-905aa9f460cc

Version: 2

Effective Time: 20221027