Label: HYDROCORTISONE cream
- NDC Code(s): 63941-312-01
- Packager: Valu Merchandisers, Co.
- 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 January 27, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use
- in or near the eyes
- by putting directly into the rectum by using fingers or any mechanical device or applicator
- for external feminine itching if you have a vaginal discharge
- for diaper rash: ask a doctor.
When using this product
for external anal itching, do not exceed recommended daily dosage unless directed by a doctor
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Directions
- apply to affected area not more than 3 to 4 times daily
- for external anal itching: when practical, clean area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
- children under 2 years, or children under 12 years with external anal itching: do not use, ask a doctor
- Other information
- Inactive ingredients
- Package label
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-312 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 BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SQUALENE (UNII: 7QWM220FJH) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63941-312-01 1 in 1 BOX 02/29/2012 1 28 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 02/29/2012 Labeler - Valu Merchandisers, Co. (868703513)