Your browser does not support JavaScript! HYDROCORTISONE CREAM [MORALES DISTRIBUTORS INC]
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HYDROCORTISONE cream
[Morales Distributors Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active ingredient

Hydrocortisone 1.0 percent

Purpose

Anti-Itch

Uses

temporarily relieves itching associated with minor skin irritation, inflammation and rashes due to

  • eczema
  • psoriasis
  • seborrheic dermatitis
  • poison ivy, oak, sumac
  • insect bites
  • soaps and detergents
  • cosmetics
  • jewerly
  • external feminine and anal itching
Other uses of this product: ask a doctor

Warnings

For external use only

Do not use

  • in or near the eyes
  • by putting directly into the rectum by using fingers or any mechanical device or applicator
  • for external feminine itching if you have a vaginal discharge
  • for diaper rash; ask a doctor

Ask a doctor or pharmacist

before use if you are using any other hydrocortisone product

When using this product

for external anal itching, do not exceed recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • rectal bleeding occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control

Directions

  • apply to affected area not more than 3 to 4 times daily
  • for external anal itching: when practical, clean area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • children under 2 years, or children under 12 years with external anal itching, do not use, ask a doctor

Other information

store at room temperature, protect from freezing

Inactive ingredients

butylated hydroxytoluene, cetyl alcohol, glycerin, glyceryl monostearate, isopropyl myristate, methylparaben, propylparaben, purified water, squalane, and stearic acid

Principal Label

NDC NO. 53210-1002-0
Compare to maximum strength Cortaid(R) active ingredient

Maximum Strength
FAST RELIEF
plus itching plus redness

Anti-Itch Cream for Skin Irritations

Relieves Itching and Redness Fast

Hydrocortisone 1 percent Cream

NET 1oz(28.3g)

Exclusively distributed by:
Morales Distributors, Inc
Mayaguez, P.R. 00682

This product is not manufactured or distributed by Pharmacia Consumer Healthcare, owner of the registered trademark Cortaid.(R)

Made in Korea

box label

box label

tube label

HYDROCORTISONE  
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53210-1002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
CETYL ALCOHOL 
GLYCERIN 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
METHYLPARABEN 
PROPYLPARABEN 
WATER 
SQUALANE 
STEARIC ACID 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53210-1002-01 in 1 BOX
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/25/2012
Labeler - Morales Distributors Inc (127151731)

Revised: 9/2012
 
Morales Distributors Inc

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