Label: HYDROCORTISONE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 67777-417-01, 67777-417-02 - Packager: Dynarex Corporation
- 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 June 23, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Warnings
- Purpose
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions:
Adults and children 2 years of age and older:
- apply evenly to affected area no more than 3 or 4 times daily. Children under 2 years of age consult a doctor
- when used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting and blotting with bathroom tissue or soft cloth before applying. Children under 12: consult doctor before using for anal itching.
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-417 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PARAFFIN (UNII: I9O0E3H2ZE) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-417-01 28.4 g in 1 TUBE; Type 0: Not a Combination Product 10/07/2016 2 NDC:67777-417-02 0.9 g in 1 PACKET; Type 0: Not a Combination Product 10/07/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/07/2016 Labeler - Dynarex Corporation (008124539) Registrant - Dynarex Corporation (008124539) Establishment Name Address ID/FEI Business Operations Gopaldas Visram & Co.,Ltd 858030888 manufacture(67777-417)