NDC | 55621-008-01 |
Set ID | cddc9c4a-7c58-4225-921a-05d6afb49178 |
Category | HUMAN OTC DRUG LABEL |
Packager | Zhejiang Jingwei Pharmaceutical Co., Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
-
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 dermatitis
-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
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.
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
- STOP USE
-
DOSAGE & ADMINISTRATION
Directions
for itching of skin irritation, inflammation and rashes:
-adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times daily
-for children under 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 more than 3 to 4 times daily
-children under 12 years of age: ask a doctor
- STORAGE AND HANDLING
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FAMILY WELLNESS
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55621-008 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 PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55621-008-01 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)