THERA  PLUS- hydrocortisone cream 
Zhejiang Jingwei Pharmaceutical Co., Ltd.

----------

Drug Facts

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

Active Ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

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

- 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


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

Warnings for external use only


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 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


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

copy of label

THERA   PLUS
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55621-001-0128 g in 1 TUBE; Type 0: Not a Combination Product03/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/01/2013
Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Jingwei Pharmaceutical Co., Ltd.530876549manufacture(55621-001)

Revised: 10/2023
Document Id: 08849eb4-ae6b-8151-e063-6394a90a5a7e
Set id: bcc99e5a-2403-46da-9c9d-8411fa4104e0
Version: 7
Effective Time: 20231025
 
Zhejiang Jingwei Pharmaceutical Co., Ltd.