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procure by TWIN MED, LLC

Medically reviewed on March 15, 2017

Dosage form: ointment
Ingredients: HYDROCORTISONE ACETATE 1g in 100g
Labeler: TWIN MED, LLC
NDC Code: 55681-224

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.

Drug Facts

Active Ingredient (per gram)

Hydrocortisone Acetate, USP (1% w/w)

Purpose

Antipruritic (Anti-Itch)


Uses

For temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external gential, 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
  • In the eyes
  • for diaper rash
  • if you have vaginal discharge
  • more than recommended dosage.

Ask a doctor before use if

you are pregnant or breast feeding

Stop use and ask a doctor if
  • the condition worsens, or if symptoms persists 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 over 2 years of age
  • Apply evenly to affected area no more than 3 to 4 times daily
  • Children under 2 years of age
  • Do not use, consult a doctor
  • Adults- When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • Gently dry, patting or blotting with bathroom tissue or soft cloth before applying
  • apply externally to the area up to 6 times daily or after bowel movment
  • After application, discard pad. Do not flush in toilet.

Other Information
  • Store at 20o-25oC(68o-77o F)
  • Avoid excessive heat and humidity.

Inactive Ingredients

Cetomacrogol 1000, Cetostearyl Alcohol, Chloracresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Metabisulphite, White Soft Paraffin.

Principal Display Panel

NDC # 55681-224-02

ProCure

HYDROCORTISONE 1% CREAM

Relief of Minor Skin Irritations, Itching and Rashes

144 PACKETS

Net Weight: 0.9 grams

Item No. PCHC09

PROCURE  
hydrocortisone acetate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-224
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETETH-20 
MINERAL OIL 
PETROLATUM 
CETOSTEARYL ALCOHOL 
EDETATE SODIUM 
PROPYLENE GLYCOL 
WATER 
SODIUM METABISULFITE 
CHLOROCRESOL 
Packaging
#Item CodePackage Description
1NDC:55681-224-02144 PACKET in 1 BOX
10.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/05/2013
Labeler - TWIN MED, LLC (009579330)
Registrant - Sion Biotext Medical Ltd (532775194)

 
TWIN MED, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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