Label: SIGNATURE CARE HYDROCORTISONE- hydrocortisone cream
- NDC Code(s): 21130-993-64
- Packager: Safeway
- 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.
Updated August 29, 2017
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- Active ingredient
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
- poison ivy, oak, sumac
- insect bites
- seborrheic dermatitis
- temporarily relieves external anal and genital itching
- other uses of this product should be only under the advice and supervision of a doctor
For external use only
Do not use
- in the genital area if you have a vaginal discharge. Ask a doctor.
- for the treatment of diaper rash. Ask a doctor.
When using this product
- avoid contact with the 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
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
- rectal bleeding occurs
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- 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: do not use, ask a doctor
- 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
- Other information
- store at 20°-25°C (68°-77°F)
- Inactive ingredients
aloe barbadensis leaf juice, aluminum sulfate, calcium acetate, cetearyl alcohol, cetyl alcohol, cholecalciferol, dextrin, glycerin, isopropyl palmitate, light mineral oil, maltodextrin, methylparaben, propylene glycol, propylparaben, purified water, retinyl palmitate, sodium cetearyl sulfate, sodium lauryl sulfate, tocopherol, white petrolatum, white wax, zea mays (corn) oilClose
- Questions or comments?
- Principal Display Panel
COMPARE TO Cortizone-10® Plus active ingredient
Hydrocortisone 1% Cream
PLUS 10 MOISTURIZERS
#1 DOCTOR RECOMMENDED ITCH RELIEF ACTIVE INGREDIENT
Dry, itchy skin
Skin irritation & rashes
Eczema & psoriasis
Moisturizes while it relieves
Enriched with vitamins A, D, E and aloe
NET WT 1 OZ (28 g)Close
- INGREDIENTS AND APPEARANCE
SIGNATURE CARE HYDROCORTISONE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-993 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM SULFATE (UNII: 34S289N54E) CALCIUM ACETATE (UNII: Y882YXF34X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) CHOLECALCIFEROL (UNII: 1C6V77QF41) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) LIGHT MINERAL OIL (UNII: N6K5787QVP) MALTODEXTRIN (UNII: 7CVR7L4A2D) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TOCOPHEROL (UNII: R0ZB2556P8) PETROLATUM (UNII: 4T6H12BN9U) WHITE WAX (UNII: 7G1J5DA97F) CORN OIL (UNII: 8470G57WFM) ICODEXTRIN (UNII: 2NX48Z0A9G) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-993-64 1 in 1 CARTON 11/10/2015 1 28 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 not final part348 11/10/2015 Labeler - Safeway (009137209)