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Family Wellness Maximum Strength Hydrocortisone

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: Family Dollar
NDC Code: 55319-074

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 ingredient                                                  Purpose

Hydrocortisone, USP 1%.......................................Anti-Itch

Uses

for the 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
  • seborrhea dermatitis
  • temporarily relieves external anal and genital itching
  • other uses for this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

  • in the 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 the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put this product into the rectum by using finger 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 of 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

Other information

  • Store at room temperature 20°-25°C (68°-77°F)
  • lot no. & exp. date: see box or see crimp of tube

Inactive ingredients

aloe vera leaf, butylated hydroxytoluene, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, water

Distributed By:

Family Dollar Services, Inc.

10401 Monroe Rd.

Matthews, NC 28105 USA

Made in Korea

FAMILY WELLNESS MAXIMUM STRENGTH HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-074
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 
BUTYLATED HYDROXYTOLUENE 
CETETH-20 
CETYL ALCOHOL 
METHYLPARABEN 
MINERAL OIL 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SORBITAN MONOSTEARATE 
STEARYL ALCOHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:55319-074-281 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/19/2013
Labeler - Family Dollar (024472631)

Revised: 09/2016
 
Family Dollar

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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