Label: MEDI-FIRST PLUS HYDROCORTISONE- 1 % hydrocortisone cream
MEDI-FIRST HYDROCORTISONE- 1 % hydrocortisone cream
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NDC Code(s):
47682-611-12,
47682-611-35,
47682-611-73,
47682-611-99, view more47682-633-73
- 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 August 10, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
Do not use
- for the treatment of diaper rash
- with any other Hydrocortisone product unless you have consulted a doctor
- if you have a vaginal discharge, consult a doctor
- KEEP OUT OF REACH OF CHILDREN.
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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: do not use and ask a doctor
For external anal and genital 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
Children under 12 years of age: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- Medi-First 1% Hydrocortisone Cream Label
- Medi-First Plus 1% Hydrocortisone Cream Label
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INGREDIENTS AND APPEARANCE
MEDI-FIRST PLUS HYDROCORTISONE
1 % hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-633 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 METHYLPARABEN (UNII: A2I8C7HI9T) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) BENZOIC ACID (UNII: 8SKN0B0MIM) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CHLORPHENESIN (UNII: I670DAL4SZ) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-633-73 25 in 1 BOX 01/01/2020 12/01/2024 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 01/01/2020 12/01/2024 MEDI-FIRST HYDROCORTISONE
1 % hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-611 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 PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CHLORPHENESIN (UNII: I670DAL4SZ) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BENZOIC ACID (UNII: 8SKN0B0MIM) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-611-35 144 in 1 BAG 01/01/2020 12/01/2024 1 0.9 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-611-73 25 in 1 BOX 01/01/2020 12/01/2024 2 0.9 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:47682-611-12 10 in 1 BOX 01/01/2020 12/01/2024 3 0.9 g in 1 PACKET; Type 0: Not a Combination Product 4 NDC:47682-611-99 0.9 g in 1 PACKET; Type 0: Not a Combination Product 01/01/2020 12/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2020 12/01/2024 Labeler - Unifirst First Aid Corporation (832947092)