NEW TEROCIN- methyl salicylate, capsaicin, and menthol lotion lotion

NEW TEROCIN by

Drug Labeling and Warnings

NEW TEROCIN by is a Otc medication manufactured, distributed, or labeled by DIRECT RX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Methyl Salicylate 25%

Capsaicin 0.025%

Menthol 10%

PURPOSE

Topical Analgesic

WHEN USING

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.

DESCRIPTION

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 INGREDIENT

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.

DOSAGE & ADMINISTRATION

INDICATIONS & USAGE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NEW TEROCIN 
methyl salicylate, capsaicin, and menthol lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-578(NDC:50488-1129)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-578-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/27/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/27/2018

Labeler - DIRECT RX (079254320)

Registrant - DIRECT RX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECT RX		079254320	relabel(61919-578)