Label: HYDROCORTISONE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 63777-248-01 - Packager: Kinray 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 June 14, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Warnings:
- Purpose
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Indications and Usage
- in the eyes
- longer than 1 week unless directed by a physician
- for diaper rash
- if you have vaginal discharge
- more than the recommended daily dosage unless directed by a doctor
- in the rectum bu using fingers or any other mechanical device or applicator
- For temporary relief of minor skin irritations and external itching.
- Stop use and ask a physician if:
- Keep out of reach of children
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Dosage and Administration
Adults and children over 2 years of age
- Apply evenly to affected area no more than 3 or 4 times daily.
- Do not use
- consult a physician
- When practical, 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
- apply externally to the area up to 6 times daily or after each bowel movement
- Other information:
- Inactive Ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63777-248 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 CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) PARAFFIN (UNII: I9O0E3H2ZE) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63777-248-01 28.4 g in 1 TUBE; Type 0: Not a Combination Product 06/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/14/2017 Labeler - Kinray Inc. (012574513) Registrant - Dynarerx Corporation (008124539)