Maximum Strength Hydrocortisone: Package Insert and Label Information


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, USP 1%




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


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.


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 applicaion of this product.

Children under 12 years of age: consult a doctor.

Other information

Storage temperature: not to exceed 30 o C (86 o F).

Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredients

mineral oil, white petrolatum

Carton Label

Carton Label
(click image for full-size original)

Tube Label

Tube Label
(click image for full-size original)

hydrocortisone ointment ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0230
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
PETROLATUM 96.98 g in 100 g
MINERAL OIL 2 g in 100 g
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0230-03 1 TUBE in 1 CARTON contains a TUBE (0363-0230-01)
1 NDC:0363-0230-01 28 g in 1 TUBE This package is contained within the CARTON (0363-0230-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 06/07/2016
Labeler — Walgreens (008965063)
Name Address ID/FEI Operations
Unipack, Inc. 009248480 manufacture (0363-0230)

Revised: 01/2022 Walgreens provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

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