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NDC 50488-1130-01 Limencin .025; 10; 25 g/100mL; g/100mL; g/100mL Details

Limencin .025; 10; 25 g/100mL; g/100mL; g/100mL

Limencin is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Alexso, Inc.. The primary component is CAPSAICIN; MENTHOL; METHYL SALICYLATE.

Product Information

NDC	50488-1130
Product ID	50488-1130_3e542a59-3145-4f02-96a5-629a3f2db3af
Associated GPIs	90809903304122
GCN Sequence Number	070568
GCN Sequence Number Description	capsaicin/me-salicylate/menth LOTION 0.025%-25% TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	34146
HICL Sequence Number	002572
HICL Sequence Number Description	CAPSAICIN/METHYL SALICYLATE/MENTHOL
Brand/Generic	Brand
Proprietary Name	Limencin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Methyl Salicylate, Capsaicin, Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	.025; 10; 25
Active Ingredient Units	g/100mL; g/100mL; g/100mL
Substance Name	CAPSAICIN; MENTHOL; 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	2023-12-31

Package

Package Images

NDC 50488-1130-01 (50488113001)

Pricing Information	N/A
NDC Package Code	50488-1130-1
Billing NDC	50488113001
Package	120 mL in 1 BOTTLE (50488-1130-1)
Marketing Start Date	2018-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 14ec08d2-7d23-49ea-88f7-eece1d5c495e Details

Active ingredients:

Methyl Salicylate 25%

Capsaicin 0.025%

Menthol 10%

Purpose

Topical Analgesic

Uses:

Temporarily relieves mild aches and pains of muscles or joints.

Warnings:

Only for external use.

Do not use:

on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.

Consult your physician:

if pain is persistent or worsens or if using any other topical pain products.

Call poison control if swallowed. If contact with the eyes occurs, rinse eyes thoroughly with cold water.

Keep out of reach of children.

Consult physician for children under 12.

Directions

Wash and dry affected area. Shake bottle well before each use and gently rub over area of pain. Use is not recommended more than four times a day. Wash hands immediately afterwards to avoid contact with eyes.

Inactive ingredients

Water (Aqua), Cetyl Alcohol, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate, Propylene Glycol, Dimethyl Sulfone, Lavandula Angustifolia (Lavendar) Oil, Lidocaine, Aloe Barbadensis Leaf Extract, Borago Officinalis Seed Oil, Boswellia Serrata Extract, Xanthan Gum, Triethanolamine, Methylparaben, Propylparaben, DMDM Hydantoin, Iodopropynyl Butylcarbamate

PRINCIPAL DISPLAY PANEL

NDC 50488-1130-1

Limencin Lotion

Topical Pain Relief

Long Lasting

Soothing Effect

120 ml (4 fl oz.)

Manufactured for: Alexso, Inc.

Los Angeles, CA 90064

Store in a dry, cool place

For Comments or Questions,

call 888.495.6078

Made in the U.S.A.

Patent Pending

PRINCIPAL DISPLAY PANEL
NDC 50488-1130-1
Limencin
Lotion
Topical Pain Relief
120 ml (4 fl oz.)

Label

INGREDIENTS AND APPEARANCE

LIMENCIN

methyl salicylate, capsaicin, menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50488-1130
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	25 g in 100 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LIDOCAINE (UNII: 98PI200987)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BORAGE SEED OIL (UNII: F8XAG1755S)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
XANTHAN GUM (UNII: TTV12P4NEE)
TROLAMINE (UNII: 9O3K93S3TK)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50488-1130-1	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/01/2018

Labeler - Alexso, Inc. (963338061)

Revised: 2/2019

Document Id: 3e542a59-3145-4f02-96a5-629a3f2db3af

Set id: 14ec08d2-7d23-49ea-88f7-eece1d5c495e

Version: 2

Effective Time: 20190212