Label: MEDI-FIRST HYDROCORTISONE 1%- hydrocortisone acetate 1% cream
MEDI-FIRST PLUS HYDROCORTISONE 1%- hydrocortisone acetate 1% cream
- NDC Code(s): 47682-980-35, 47682-980-73, 47682-981-73
- Packager: Unifirst First Aid Corporation
- 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 20, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- for adults and children 2 years of age and older: apply to the affected area 3 to 4 times daily
- children under 12 years of age: for external anal itching, consult a doctor
- children under 2 years of age: do not use, consult a doctor
- adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with appropriate cleansing pad
- gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MEDI-FIRST HYDROCORTISONE 1%
hydrocortisone acetate 1% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-980 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-980-35 144 in 1 BOX 04/01/2023 1 0.9 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-980-73 25 in 1 PACKET 04/01/2023 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 04/01/2023 MEDI-FIRST PLUS HYDROCORTISONE 1%
hydrocortisone acetate 1% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-981 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-981-73 25 in 1 PACKET 04/01/2023 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 04/01/2023 Labeler - Unifirst First Aid Corporation (832947092) Establishment Name Address ID/FEI Business Operations Medique Products 086911794 pack(47682-980, 47682-981) Establishment Name Address ID/FEI Business Operations Prestige Packaging 080667761 pack(47682-980, 47682-981)
