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 Anti-Itch Cream content of label

Active ingredient
Hydrocortisone 1%

Purpose
Anti-itch

Uses

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

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

image of 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
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)  
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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Melaleuca, Inc.139760102manufacture

Revised: 11/2011
Document Id: d36aedc4-fb4f-43f0-bf9c-89593671db06
Set id: a0962a88-8a49-414c-aecf-db94ec033f16
Version: 1
Effective Time: 20111109
 
Melaleuca, Inc.