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Family Wellness by FRONT PHARMACEUTICAL PLC

Medically reviewed on June 18, 2017

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: FRONT PHARMACEUTICAL PLC
NDC Code: 69571-009

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.

Active ingredients

Hydrocortisone 1%

Purpose

Anti-itch

Uses

•temporarily relieves itching associated with minor skin

irritations, inflammation and rashes due to:

   •eczema  •psoriasis  •poison ivy, oak, sumac

   •insect bites  •detergents  •jewelry

   •cosmetics  •soaps  •saborrheiic dermatitis

•temproarily relieves external and genital itching

•other uses of this product should be under advice and

supervision of a doctor

Warnings  For external use only.

Do not use:

•in the genital area if you have 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 told to do so by a doctor.

•do not put directly into rectum by using fingers or

any mechanical device or applicator.

Stop use and ask a doctor if

•condition worsens, symptoms persist for more than 7 days

or clear up and occur again within a few days, and do not

begin use of any other hydrocortisone product unless you

have asked a doctor  •rectal bleeding occurs

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.

Directions

•for itching or skin irritation, inflammation and rashes:

   •adults and children 2 years of age and older: apply to

   affected area not more than 3 to 4 times daily

   •children under 2 years of age: ask a doctor

•for external and genital itching, adults:

   •when practical, clean the affected area with mild soap

   and warm waterand rinse thoroughly

   •gently dry by patting or blotting with toilet tissue or soft

   cloth before applying

   •apply to 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)

Inactive ingredients aloe barbadensis leaf juice,

ceteastrearyl alcohol, edetate disodium, glyceryl

monostearate, methylparaben, mineral oil, polysorbate

60, propylene glycol, span 60, water, white petrolatum

Questions?  1-800-638-3800  Weekdays 0 AM to 4 PM EST

FAMILY WELLNESS 
hydrocortisone 1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-009
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CETOSTEARYL ALCOHOL 
EDETATE DISODIUM 
GLYCERYL MONOSTEARATE 
METHYLPARABEN 
MINERAL OIL 
POLYSORBATE 60 
PROPYLENE GLYCOL 
SORBITAN MONOSTEARATE 
WATER 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:69571-009-011 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/18/2017
Labeler - FRONT PHARMACEUTICAL PLC (530897792)
Establishment
NameAddressID/FEIOperations
FRONT PHARMACEUTICAL PLC530897792manufacture(69571-009)

 
FRONT PHARMACEUTICAL PLC

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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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