DermaCort

DermaCort

Drug Labeling and Warnings

Drug Details

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DERMACORT ANTI-ITCH- hydrocortisone cream 
Melaleuca, Inc.

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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DermaCort

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 jewelery
  • Other use of this product should be only under the advice and supervision of a doctor.

Warnings
For external use only.

When using this product avoid contact with the eyes.

Stop use and ask a doctor if conditions worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Do not use for the treatment of diaper rash. Consult a doctor.

Keep out of reach of children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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, consult a doctor.

Other information Do not store above 100°F.

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, Serareth-2, Steareth-21, Triethanolamine.

DermaCort label

DERMACORT  ANTI-ITCH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54473-117
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
TEA TREE OIL (UNII: VIF565UC2G)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54473-117-2828 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/02/2000
Labeler - Melaleuca, Inc. (139760102)
Registrant - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.079711683manufacture(54473-117)

Revised: 3/2018
 
Melaleuca, Inc.


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