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Hydrocortisone Maximum Strength

Medically reviewed on October 10, 2017

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: Preferred Pharmaceuticals, Inc.
NDC Code: 68788-9800

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.

Hydrocortisone Cream, USP 1% with Aloe

ACTIVE INGREDIENT

Hydrocortisone, USP 1%

PURPOSE

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
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
for external feminine itching 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 begin the use of any other hydrocortisone product unless directed by a doctor
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 occur again in a few days
rectal bleeding occurs, consult doctor promptly

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

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
do not use, consult a doctor
 
For external anal itching
 
Adults: when practical, clean the affected 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 12 years of age: consult a doctor

OTHER INFORMATION
Store at room temperature 59°-86°F (15°-30°C).  Protect from freezing.
Before using any medication, read all label directions.  Keep carton, it contains important information.

INACTIVE INGREDIENT

aloe vera concentrate, cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax.  May contain citric acid or sodium citrate solution to adjust pH.

QUESTIONS

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

28g tube - 68788-9800-2

Anti-itch Cream

Hydrocortisone CREAM USP 1% WITH ALOE

Compare to the active ingredient in Cortaid® Maximum Strength Cream*

MAXIMUM STRENGTH

Maximum Strength Formula for Temporary Relief of Itching Associated with Irritations, Inflammations and Rashes Due to:

Poison Ivy, Oak, Sumac
Eczema
Insect Bites
Seborrheic Dermatitis
External Genital, Feminine or Anal Itch

NET WT 1 OZ (28 g)

 
03390311F1 VC110438
HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem 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, UNSPECIFIED FORM 
SORBIC ACID 
Packaging
#Item CodePackage Description
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)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals, Inc.791119022RELABEL(68788-9800)

 
Preferred Pharmaceuticals, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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