Label: THERA PLUS- hydrocortisone cream
- NDC Code(s): 55621-001-01
- Packager: Zhejiang Jingwei Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 25, 2023
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- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
- 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
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
-
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
-
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 creamProduct 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 Drug M017 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)