Label: HYDROCORTISONE cream
Contains inactivated NDC Code(s)
NDC Code(s): 76413-311-30
- Packager: Central Texas Community Health Centers
- This is a repackaged label.
- Source NDC Code(s): 0603-0535
- 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 April 8, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
- insect bites
- seborrheic dermatitis
- external genital and anal itching
- poison ivy, poison oak, or poison sumac
Other uses of this product should be only under the advice and supervision of a doctor.
- For external use only
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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.
For external anal itching
- adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product
- children under 12 years of age with external anal itching: consult a doctor
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 28 g Tube Label
CommUnityCare Federally Qualified Health Centers
1% CR 28g
USE AS DIRECTED.
HYDROCORTISONE 1% CRM 30G NDC 76413-311-30
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-311(NDC:0603-0535) 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 CETYL ALCOHOL (UNII: 936JST6JCN) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) MINERAL OIL (UNII: T5L8T28FGP) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) POLYSORBATE 40 (UNII: STI11B5A2X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0) WATER (UNII: 059QF0KO0R) SORBIC ACID (UNII: X045WJ989B) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76413-311-30 1 in 1 CARTON 10/01/2001 1 28.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 10/01/2001 Labeler - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Central Texas Community Health Centers 079674019 REPACK(76413-311) , RELABEL(76413-311)