DermaCort Anti-Itch

Dosage form: cream
Ingredients: HYDROCORTISONE 10mg in 1g
Labeler: Melaleuca, Inc.
NDC Code: 54473-117

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.

Dermacort Anti-Itch Cream content of label

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, psoriasis, seborrheic dermatitis, poison ivy, poison oak, poison sumac, insect bites, soaps, detergents, and jewelry
  • 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.

When using this product avoid contact with the eyes

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, and do not begin use of any other hydrocortisone product unless you have asked a doctor

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.

Other information do not store above 100°F (38°C)

Inactive ingredients acrylates/C10-30 alkyl acrylates crosspolymer, cetyl alcohol, cyclopentasiloxane, deionized water, dimethicone, glycerin USP, glyceryl stearate and PEG-100 stearate, isopropyl palmitate, Melaleuca Oil, methylparaben, petrolatum USP, propylparaben, steareth-2, steareth-21, triethanolamine

DERMACORT  ANTI-ITCH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-117
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CETYL ALCOHOL 
CYCLOMETHICONE 5 
DIMETHICONE 
GLYCERIN 
GLYCERYL MONOSTEARATE 
ISOPROPYL PALMITATE 
METHYLPARABEN 
PETROLATUM 
POLYOXYL 100 STEARATE 
PROPYLPARABEN 
STEARETH-2 
STEARETH-21 
TEA TREE OIL 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:54473-117-0128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/02/2000
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIOperations
Melaleuca, Inc.139760102manufacture

Revised: 11/2011
 
Melaleuca, Inc.

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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