HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream 
Preferred Pharmaceuticals, Inc

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.

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Hydrocortisone Cream, USP 1% with Aloe

ACTIVE INGREDIENT

Hydrocortisone 1%

PURPOSE

Anti-itch

USES

For the temporary relief of itching due to minor skin irritations, inflammation, and rashes from:

•
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

WARNINGS

For external use only

DO NOT USE

•
in the eyes
•
for external feminine itching if you have a vaginal discharge
•
for the treatment of diaper rash

WHEN USING THIS PRODUCT

•
do not begin the use of any other hydrocortisone product
•
for external anal itching:
•
do not use more than directed unless directed by a doctor
•
do not put this product into the rectum by using fingers or any mechanical device or applicator

STOP USE AND ASK A DOCTOR IF

•
symptoms last for more than 7 days
•
the condition gets worse
•
symptoms clear up and come back in a few days
•
rectal bleeding occurs, consult promptly

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

For general use

•
adults and children 2 years and older: apply to affected area not more than 3 to 4 times a day
•
children under 2 years: do not use, ask a doctor

For external anal itching

•
adults and children 12 years and older: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with a toilet tissue or a soft cloth before application of this product
•
children under 12 years: ask a doctor

INACTIVE INGREDIENTS

Aloe vera concentrate, cetyl alcohol, citric acid, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, sorbic acid, sorbitan monostearate, stearyl alcohol, and white wax.

HOW SUPPLIED

28g tube - 68788-9800-2

Relabeled By Preferred Pharmaceuticals, Inc

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrocortisone 1% cream label
HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68788-9800(NDC:0472-0339)
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 
CETYL ALCOHOL 
CITRIC ACID MONOHYDRATE 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
METHYLPARABEN 
SORBITAN MONOSTEARATE 
STEARYL ALCOHOL 
WHITE WAX 
POLYOXYL 40 STEARATE 
POLYSORBATE 60 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
SORBIC ACID 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-9800-228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/30/2012
Labeler - Preferred Pharmaceuticals, Inc (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc791119022RELABEL(68788-9800)

Revised: 4/2012
Document Id: 67b8fab6-0e22-4ed1-a7c1-0c4191ee9341
Set id: 67b8fab6-0e22-4ed1-a7c1-0c4191ee9341
Version: 1
Effective Time: 20120430
 
Preferred Pharmaceuticals, Inc