1 HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment 
American Sales Company

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

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
•
seborrheic dermatitis
•
temporarily relieves external anal and genital itching
•
other uses of this product should only be 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. Ask a doctor.
•
for the treatment of diaper rash. Ask 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 directly into the 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 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: do not use, ask a doctor
•
for external anal and genital itching, adults:
•
when practical, clean the affected area with mild soap and warm water and rinse thoroughly
•
gently dry by patting or blotting with toilet tissue or a 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 20°-25°C (68°-77°F)

Inactive ingredients

aloe barbadensis leaf juice, white petrolatum

Principal Display Panel

Compare to the Active Ingredient in Cortizone•10®

MAXIMUM STRENGTH

1% HYDROCORTISONE

ANTI-ITCH OINTMENT

Relieves Itch Fast!

Skin Irritation

Rashes

Insect bites

Eczema & Psoriasis

Inflammation & Redness

Water resistant formula helps seal in healing

1% Hydrocortisone Carton Image 1
1% Hydrocortisone Carton Image 2
1 HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-201
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 
PETROLATUM 
Product Characteristics
ColorWHITE (clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-201-641 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/17/2012
Labeler - American Sales Company (809183973)

Revised: 01/2013
Document Id: 1b5091e1-1800-4f48-9efc-c045222f8885
Set id: 1b5091e1-1800-4f48-9efc-c045222f8885
Version: 1
Effective Time: 20130123
 
American Sales Company