Label: ITCH RELIEF- hydrocortisone cream
- NDC Code(s): 70677-1215-1
- Packager: STRATEGIC SOURCING SERVICES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 16, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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Uses
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
- eczema
- psoriasis
- poison ivy, oak, sumac
- insect bites
- detergents
- jewelry
- cosmetics
- soaps
- seborrheic dermatitis
- temporarily relieves external anal and genital itching
- other uses of this product should only be under the advice and supervision of a doctor
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
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Warnings
For external use only
Do not use
- in the genital area if you have a vaginal discharge. Consult a doctor.
- for the treatment of diaper rash. Consult a doctor.
When using this product
- avoid contact with eyes
- do not use more than directed unless told to do so by a doctor
- do not put directly into the rectum by using fingers or any mechanical device or applicator
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Directions
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for itching of skin irritation, inflammation, and rashes:
- 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: ask a doctor
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for external anal and genital itching, adults:
- when practical, clean the 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
- apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: ask a doctor
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for itching of skin irritation, inflammation, and rashes:
- Other information
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Inactive ingredients
aloe powder, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile oil, citric acid, corn oil, glycerin, glyceryl monostearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin wax, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A & vitamin D3 liquid, vitamin E, white petrolatum.
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
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INGREDIENTS AND APPEARANCE
ITCH RELIEF
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1215 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 cetostearyl alcohol (UNII: 2DMT128M1S) sodium lauryl sulfate (UNII: 368GB5141J) sodium cetostearyl sulfate (UNII: 7ZBS06BH4B) chamomile flower oil (UNII: 60F80Z61A9) citric acid monohydrate (UNII: 2968PHW8QP) corn oil (UNII: 8470G57WFM) glycerin (UNII: PDC6A3C0OX) glyceryl monostearate (UNII: 230OU9XXE4) isopropyl palmitate (UNII: 8CRQ2TH63M) maltodextrin (UNII: 7CVR7L4A2D) methylparaben (UNII: A2I8C7HI9T) mineral oil (UNII: T5L8T28FGP) paraffin (UNII: I9O0E3H2ZE) petrolatum (UNII: 4T6H12BN9U) propylene glycol (UNII: 6DC9Q167V3) propylparaben (UNII: Z8IX2SC1OH) water (UNII: 059QF0KO0R) stearyl alcohol (UNII: 2KR89I4H1Y) Vitamin A (UNII: 81G40H8B0T) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CHOLECALCIFEROL (UNII: 1C6V77QF41) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1215-1 1 in 1 CARTON 01/10/2024 1 28.4 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 Drug M017 01/10/2024 Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)
