THERAPLUS PLUS- clotrimazole cream

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 glycerin, glyceryl stearate se, laureth-23, methylparaben, mineral oil, prophylparaben, stearic acid, stearyl alcohol, water

ACTIVE INGREDIENT

Active Ingredient

Clotrimazole 1%

WARNINGS

Warnings

For external use only

Do not use

on children under 2 years of age unless directed by a doctor

on the scalp or nails

When using this product

avoid contact with eyes

PURPOSE

Purpose

Antifungal

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  relieves itching, burning, cracking, scaling and discomfort associated with:

-athletes foot      -jock itch      -ring worm

DOSAGE & ADMINISTRATION

Directions

-wash and dry affected area thoroughly

-apply a thin layer to affected area 2 times daily

-for athlete's foot and ringworm, use daily for up to 4 weeks

-for jock itch, use daily for up to 2 weeks

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERAPLUS   PLUS
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55621-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
LAURETH-23 (UNII: N72LMW566G)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55621-003-01	35 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 final	part333C	03/01/2013

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

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Jingwei Pharmaceutical Co., Ltd.		530876549	manufacture(55621-003)