Your browser does not support JavaScript! HYDROCORTISONE OINTMENT [MOORE MEDICAL LLC]
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HYDROCORTISONE ointment
[Moore Medical LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

First Aid

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses:

  • 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, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
  • 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 treatment of diaper rash

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:

  • for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily
  • children under 2 years of age: do not use, consult a doctor
  • adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • children under 12 years of age: for external anal itching, consult a doctor

Other Information:

  • store at room temperature (do not freeze)
  • tamper evident sealed packets
  • do not use any opened or torn packets

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55670-800
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
alcohol 
methylparaben 
mineral oil 
paraffin 
petrolatum 
propylparaben 
water 
white wax 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55670-800-01144 in 1 BOX
11.0 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/12/2012
Labeler - Moore Medical LLC (051420107)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(55670-800)

Revised: 2/2013
 
Moore Medical LLC

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