Label: HYDROCORTISONE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61010-4402-1 - Packager: Safetec of America, Inc.
- Category: HUMAN OTC DRUG LABEL
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 November 1, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only
Do not use
- In the eyes
- For diaper rash
- For external genital or feminine itching if you have a vaginal discharge
- More than the recommended daily dosage unless directed by a doctor
- This product in the rectum by using fingers or any mechanical device or applicator
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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: consult a doctor
- When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching
- Other Information
- Inactive Ingredients
- Principal Display Panel - 1 oz. Tube Label
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-4402 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 CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61010-4402-1 28.4 g in 1 TUBE; Type 0: Not a Combination Product 11/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/01/2019 Labeler - Safetec of America, Inc. (874965262) Registrant - Safetec of America, Inc. (874965262)