Hydrocortisone: Package Insert and Label Information

HYDROCORTISONE- hydrocortisone cream
Central Texas Community Health Centers

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
seborrheic dermatitis
soaps
external genital 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 the treatment of diaper rash. Ask a doctor.
for external genital itching if you have a vaginal discharge. Ask a doctor.

When using this product

avoid contact with the eyes
do not begin use of any other hydrocortisone product unless you have asked a doctor
for external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
do not put this product 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

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. Ask a doctor.

for external anal 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 application of this product.
children under 12 years of age with external anal itching: ask a doctor

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe vera gel, ceteareth-20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, purified water

Questions or comments?

1-800-719-9260

PRINCIPAL DISPLAY PANEL — 28 g Tube Label

CommUnityCare Federally Qualified Health Centers

HYDROCORTISONE 1% CR 28g

Date:

Name: Dr.

USE AS DIRECTED.

1/1/01

123456

HYDROCORTISONE 1% CRM 30G NDC 76413-339-28

Batch: 123456
Lot: 123456
Exp: 1/1/01
PERRIGO

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

PRINCIPAL DISPLAY PANEL -- 28 g Tube Label
(click image for full-size original)
HYDROCORTISONE
hydrocortisone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-339(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
ALOE VERA LEAF
POLYOXYL 20 CETOSTEARYL ETHER
CETOSTEARYL ALCOHOL
CETYL PALMITATE
GLYCERIN
ISOPROPYL MYRISTATE
METHYLPARABEN
WATER
ISOSTEARYL NEOPENTANOATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76413-339-28 28 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 04/13/2011
Labeler — Central Texas Community Health Centers (079674019)
Establishment
Name Address ID/FEI Operations
Central Texas Community Health Centers 079674019 REPACK (76413-339), RELABEL (76413-339)

Revised: 08/2017 Central Texas Community Health Centers

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