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Family Wellness by Zhejiang Jingwei Pharmaceutical Co., Ltd.

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: Zhejiang Jingwei Pharmaceutical Co., Ltd.
NDC Code: 55621-008

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Inactive Ingredients   white petrolatum

Active Ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

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. If swallowed, get medical help or contact a

Poison Control Center right away.

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 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

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

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

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

FAMILY WELLNESS  
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-008
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:55621-008-0128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2013
Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)

Revised: 07/2013
 
Zhejiang Jingwei Pharmaceutical Co., Ltd.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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