THERAPLUS PLUS- menthol ointment

TheraPlus by

Drug Labeling and Warnings

TheraPlus by is a Otc medication manufactured, distributed, or labeled by Zhejiang Jingwei Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

Inactive Ingredients   carbomer, laureth-23, methylparaben, mineral oil, propylene glycol, propylparaben, stearamidoethyl diethylamine, stearic acid, stearyl alcohol, triethanomoline, water

ACTIVE INGREDIENT

Active Ingredient

Menthol 10%

Menthol salicylate 15%

WARNINGS

Warnings

For external use only.

Do not use

-on wounds or damaged skin -with a heating pad   - on a child under 12 years of age with arthritis-like condition

When using this product

-avoid contact with eyes and mucous membranes      -do not bandage tightly

PURPOSE

Purpose

Topical analgesic

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Uses  temporarily relieves minor aches and pains of muscles and joints associated with:

-simple backache   -arthritis   -bruises   -strains   -sprains

DOSAGE & ADMINISTRATION

Directions

-adults and children 12 years of age and older:  apply to all affected area not more than 3 to 4 times daily

-children under 12 years of age: ask a doctor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERAPLUS   PLUS
menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55621-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	MENTHYL SALICYLATE, (+/-)-	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LAURETH-23 (UNII: N72LMW566G)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55621-004-01	28 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2013

Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Jingwei Pharmaceutical Co., Ltd.		530876549	manufacture(55621-004)