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

First Aid

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses:

Warnings

Ask a doctor before use:

  • if you have a vaginal discharge (for external feminine itching)
  • for external itching, do not exceed the recommended daily dosage, or if bleeding occurs
  • if condition worses or if symptoms persist for more than 7 days or clear up and occur again within a few days

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 use:

  • with any other Hydrocortisone product unless you have consulted a doctor

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Other Information:

Inactive ingredients:

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

Questions or Comments? 1-800-234-1464

PRINCIPAL DISPLAY PANEL – 144 count box

mooremedical
Supporting Health & Care

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

MooreBrand
Hydrocortisone
Cream 1%
144 Packets
Each Packet Net. Wt. 1.0gm

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

PRINCIPAL DISPLAY PANEL – 144 count box
HYDROCORTISONE 
hydrocortisone ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55670-800
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55670-800-01 144 in 1 BOX
1 1.0 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 07/12/2012
Labeler - Moore Medical LLC (051420107)
Registrant - Safetec of America, Inc. (874965262)
Establishment
Name Address ID/FEI Business Operations
Safetec of America, Inc. 874965262 MANUFACTURE(55670-800)

Revised: 2/2013
Document Id: 047e58dd-0fdf-40bd-a15b-926864e41ab5
Set id: 29b87306-0a9b-4ac9-84fa-ab120bd1cbac
Version: 2
Effective Time: 20130211
 
Moore Medical LLC