FAMILY WELLNESS- hydrocortisone cream

Family Wellness by

Drug Labeling and Warnings

Family Wellness 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   white petrolatum

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 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

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.

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

Stop use and ask a doctor if

-symptoms last for more than 7 days

-the conditions get worse

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

-rectal bleeding occurs

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

Other Information store at room temperature 68-77 F (20-25 C)

QUESTIONS

Questions? 1-800-639-3803 Weekdays 9AM to 4 PM EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS  
hydrocortisone cream

Product 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)