Hydrocortisone: Package Insert and Label Information

HYDROCORTISONE- 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.

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
eczema
insect bites
poison ivy, oak, or sumac
soaps
detergents
cosmetics
jewelry
seborrheic dermatitis
psoriasis
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. Consult a doctor.
for the treatment of diaper rash. Consult a doctor.

When using this product

avoid contact with 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 (1-800-222-1222).

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: ask a doctor
for external anal and genital itching, adults:
when practical, cleanse 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

Inactive ingredients

water, cetearyl alcohol, ceteareth-20, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, aloe barbadensis leaf juice

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Cortaid® active ingredient

Hydrocortisone Cream 1%

Anti-Itch Cream Maximum Strength

NET WT 1 LB (454 g)

Hydrocortisone  1% cream
(click image for full-size original)
HYDROCORTISONE
hydrocortisone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-8078(NDC:45802-438)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
CETOSTEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
CETYL PALMITATE
GLYCERIN
ISOPROPYL MYRISTATE
ISOSTEARYL NEOPENTANOATE
METHYLPARABEN
ALOE VERA LEAF
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-8078-2 1 TUBE in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (68788-8078-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 09/03/2021
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 RELABEL (68788-8078)

Revised: 09/2021 Preferred Pharmaceuticals Inc.

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