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NDC 50488-1015-01 Methyl Salicylate 250 mg/g Details

Methyl Salicylate 250 mg/g

Methyl Salicylate is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Alexso, Inc. The primary component is METHYL SALICYLATE.

Product Information

NDC	50488-1015
Product ID	50488-1015_de688d51-edff-4eec-98c1-0ee168638ae5
Associated GPIs	90800050003740
GCN Sequence Number	006052
GCN Sequence Number Description	methyl salicylate CREAM (G) 25 % TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	23712
HICL Sequence Number	002595
HICL Sequence Number Description	METHYL SALICYLATE
Brand/Generic	Generic
Proprietary Name	Methyl Salicylate
Proprietary Name Suffix	n/a
Non-Proprietary Name	Methyl Salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	250
Active Ingredient Units	mg/g
Substance Name	METHYL SALICYLATE
Labeler Name	Alexso, Inc
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 50488-1015-01 (50488101501)

Pricing Information	N/A
NDC Package Code	50488-1015-1
Billing NDC	50488101501
Package	120 g in 1 BOTTLE (50488-1015-1)
Marketing Start Date	2019-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eef555d3-f23d-4847-93f3-fa7a06072a0f Details

SPL UNCLASSIFIED SECTION

Methyl Salicylate 25% Cream

Alexso, Inc

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Methyl Salicylate 25% Cream

Drug Facts

Active ingredient

Methyl Salicylate 25%

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, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine

Methyl Salicylate 25% Cream

NDC: 50488-1015-5

50 grams

Methyl Salicylate 25% Cream

NDC: 50488-1015-1

120 grams

Manufactured for:

Alexso, Inc

Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

NDC 50488-1015-1

Methyl Salicylate 25% Cream

120 grams

Principal Display Panel

NDC 50488-1015-5

Methyl Salicylate 25% Cream

50 grams

INGREDIENTS AND APPEARANCE

METHYL SALICYLATE

methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50488-1015
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	250 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)
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
Packaging
1	NDC:50488-1015-1	120 g in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2019
2	NDC:50488-1015-5	50 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: 1/2022

Document Id: de688d51-edff-4eec-98c1-0ee168638ae5

Set id: eef555d3-f23d-4847-93f3-fa7a06072a0f

Version: 3

Effective Time: 20220101

Search by Drug Name or NDC

NDC 50488-1015-01 Methyl Salicylate 250 mg/g Details

Methyl Salicylate 250 mg/g

Product Information

Package

Package Images

NDC 50488-1015-01 (50488101501)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL eef555d3-f23d-4847-93f3-fa7a06072a0f Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL

Principal Display Panel

INGREDIENTS AND APPEARANCE

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