DERMACORT ANTI-ITCH- hydrocortisone cream

DermaCort by

Drug Labeling and Warnings

DermaCort by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Hydrocortisone 1%

PURPOSE

Purpose
Anti-itch

INDICATIONS & USAGE

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

Warnings
For external use only

DO NOT USE

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

WHEN USING

When using this product avoid contact with the eyes

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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.
  

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMACORT  ANTI-ITCH
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-117
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-117-01	28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/02/2000

Labeler - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc.		139760102	manufacture