THERA PLUS- hydrocortisone cream

Thera by

Drug Labeling and Warnings

Thera 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  aloe barbadensis leaf extract, glycerin, glyceral stearate, methylparaben, mineral oil, petrolatum, propylparaben, sodium lauryl sulfate, stearyl alcohol, water

ACTIVE INGREDIENT

Active Ingredient

Hydrocortisone, USP 1%

PURPOSE

Purpose

Anti-itch

INDICATIONS & USAGE

Uses - for temporary relief of itching associated with minor skin irritations,inflammation and rashes due to:

- eczema           -insect bites          -poison ivy

-poison oak      -poison sumac      -soaps

-jewelry            -detergents            -cosmetics

-psoriasis         -seborrheic dermatisis

-for external genital, feminine and anal itching

-other uses of this product should be only under the advice and supervision of a doctor

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.

WARNINGS

Warnings
for external use only

STOP USE

Do not use

-in genital area if you have a vaginal discharge. Consult a doctor

-for the treatment of diaper rash. Consult a doctor

Stop use and ask a doctor if

-symptoms last for more than 7 days

-the condition gets worse

-symptoms clear up and then occur again within a few days

-rectal bleeding occurs

WHEN USING

When using this product

-avoid contact with eyes

-do not use more than directed unless directed by a doctor

-do not put this product into the rectum by using fingers or any other mechanical device or applicator

DOSAGE & ADMINISTRATION

Directions

for itching of skin irritation, inflammation and rashes:

-adults and children 2 years of age and older: apply to the affected areanot more than 3 to 4 times dailt

-for children udner 2 years of age: ask a doctor

for external anal and genital itching, adults:

-clean the affected area with mild soap and warm water and rinse clean.

-dry the affected area before applying

-apply to the affected area not mroe than 3 to 4 times daily

-children under 12 years of age: ask a doctor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERA  PLUS
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55621-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55621-001-01	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(55621-001)