Label: PS-2896 HYDROCORTISONE CREAM 1%, 0.9G cream
- NDC Code(s): 58228-2896-1
- Packager: ProStat First Aid LLC
- 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 July 14, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use(s)
-
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 • In the rectum by using fingers or any mechanical device or applicator
-
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 Ingredient
- Questions?
- Label
-
INGREDIENTS AND APPEARANCE
PS-2896 HYDROCORTISONE CREAM 1%, 0.9G
ps-2896 hydrocortisone cream 1%, 0.9g creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58228-2896 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 METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WHITE PETROLATUM (UNII: B6E5W8RQJ4) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Product Characteristics Color Score Shape FREEFORM Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58228-2896-1 2000 in 1 CARTON 07/31/2023 1 0.9 g in 1 PACKET; 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 07/31/2023 Labeler - ProStat First Aid LLC (061263699) Registrant - Dynarex Corporation (008124539)