Label: DERMACORT ANTI-ITCH- hydrocortisone cream
- NDC Code(s): 54473-117-28
- Packager: Melaleuca, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 22, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
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
- WHEN USING
- STOP USE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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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 creamProduct 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)
