Your browser does not support JavaScript! 1 HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) OINTMENT [AMERICAN SALES COMPANY]
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1 HYDROCORTISONE MAXIMUM STRENGTH (hydrocortisone) ointment
[American Sales Company]


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%

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

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Cortizone‚óŹ10®

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

NET WT 1 OZ (28 g)

CareOne 1% Hydrocortisone 1.jpg
CareOne 1% Hydrocortisone 2.jpg
1 HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
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: 10/2013
 
American Sales Company

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