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

WARNINGS

Warnings
For external use only.

WHEN USING

When using this product avoid contact with the eyes.

STOP USE

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

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

KEEP OUT OF REACH OF CHILDREN

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

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, consult a doctor.

STORAGE AND HANDLING

Other information Do not store above 100°F.

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, Serareth-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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-117-28	28 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018

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)

Registrant - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc.		079711683	manufacture(54473-117)