HYDROCORTISONE- hydrocortisone ointment
Moore Medical LLC

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.

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Hydrocortisone Cream

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Antipruritic (Anti-itch)

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation and rashes
for external genital, feminine 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 teatment of diaper rash
with any other Hydrocortisone product unless you have consulted a doctor
if you have vaginal discharge, consult a doctor

When using this product

avoid contact with eyes
do not put this product into rectum by using fingers or any mechanical device or applicator
do not exceed recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days
symptoms clear up and reappear again within a few days
rectal bleeding occurs

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 the affected area not more than 3 to 4 times daily

Children under 2 years of age:

ask a doctor

For external and genital itching in adults:

when practical, clean affected area with mild soap and warm water and rinse thoroughly
gently dry by patting or blotting with toilet tissue or a soft cloth beforeapplying

Children under 2 years of age:

ask a doctor

Other Information

store at room temperature 59° to 86° F (15° to 30º C)
tamper evident, do not use if packet is torn, cut or opened
avoid excessive heat and humidity

Inactive ingredients:

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Questions or Comments?

1-800-234-1464

Moore Medical Hydrocortisone Cream 1% Label

mooremedical
Supporting Health & Care

Reorder No. 82464
UPN# 0-0607415-82464-3

MooreBrand®
Hydrocortisone
Cream 1%
144 Packets
Each Packet Net. Wt. 0.9gm

Temporary relief of itching
associated with minor skin irritation,
inflammation and rashes.

To reorder:
Call: 1.800.234.1464
Fax: 1.800.944.6667
Online:
www.mooremedical.com

Moore Medical

HYDROCORTISONE
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55670-800
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55670-800-01	144 in 1 BOX	07/12/2012	05/05/2022
1		1 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/12/2012	05/05/2022

Labeler - Moore Medical LLC (051420107)

Revised: 10/2021

Document Id: ce291e69-b61e-18c2-e053-2a95a90a0af9

Set id: 29b87306-0a9b-4ac9-84fa-ab120bd1cbac

Version: 7

Effective Time: 20211012

Moore Medical LLC