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NDC 50488-1129-01 New Terocin .025; 10; 25 g/100mL; g/100mL; g/100mL Details

New Terocin .025; 10; 25 g/100mL; g/100mL; g/100mL

New Terocin 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	50488-1129
Product ID	50488-1129_d99af9ae-4312-4518-b8ac-469efc619075
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	New Terocin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Methyl Salicylate, Capsaicin, and 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	2024-12-31

Package

Package Images

NDC 50488-1129-01 (50488112901)

Pricing Information	N/A
NDC Package Code	50488-1129-1
Billing NDC	50488112901
Package	120 mL in 1 BOTTLE (50488-1129-1)
Marketing Start Date	2013-03-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5dbd5fc0-a27e-4979-aca7-28f73096fd5f 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.

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:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Borago Officinalis (Borage) Seed Oil, Boswellia Serrata Extract, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetyl Alcohol, Diazolidinyl Urea, Dimethyl Sulfone (DMSO), DMDM Hydantoin, Glyceryl Stearate, Lavandula Angustifolia (Lavender) Oil, Methyl Paraben, PEG-100 Stearate, Polysorbate-20, Polysorbate-60, Propyl Paraben, Propylene Glycol, Stearic Acid, Stearyl Alcohol, Triethanolamine, Xanthan Gum.

Package/Label Principal Display Panel

NDC 50488-1129-1

New Terocin

Topical Pain

Relief Lotion

Long Lasting

Soothing Effect

120 ml (4 fl oz.)

Manufactured for: Alexso Inc.

Los Angeles, CA 90064

Store in a dry, cool place

Made in U.S.A.

Patent Pending

For Comments or Questions,

call 888-495-6075

Label

INGREDIENTS AND APPEARANCE

NEW TEROCIN

methyl salicylate, capsaicin, and menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50488-1129
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
LAVENDER OIL (UNII: ZBP1YXW0H8)
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)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50488-1129-1	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/13/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/13/2013

Labeler - Alexso Inc. (963338061)

Revised: 8/2022

Document Id: d99af9ae-4312-4518-b8ac-469efc619075

Set id: 5dbd5fc0-a27e-4979-aca7-28f73096fd5f

Version: 6

Effective Time: 20220818