Label: HYDROCORTISONE 1%- hydrocortisone cream
- NDC Code(s): 69396-118-09, 69396-118-25
- Packager: Trifecta Pharmaceuticals Usa 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 May 31, 2023
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- Official Label (Printer Friendly)
- DRUG FACTS
- Active ingredient
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Do Not Use
- Warnings
- When using this product
- Stop using this product and ask a doctor if
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Directions
Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.
Children under 2 years of age: do not use and ask a doctor.
For External and anal itching in adults:
When practical, clean affected area with mild soap and warm water and rinse thoroughly
Gently dry by patting or blotting with toilet tissue or a soft cloth before applying
For External anal and genital itching in children under 12 years of age:
Ask a doctor
- Inactive ingredients
- Other information
- SPL UNCLASSIFIED SECTION
- Questions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE 1%
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-118 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 PHENOXYETHANOL (UNII: HIE492ZZ3T) MINERAL OIL (UNII: T5L8T28FGP) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-118-09 144 in 1 CARTON 05/31/2023 1 0.9 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:69396-118-25 25 in 1 BOX 05/31/2023 2 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 05/31/2023 Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)