Label: CAREALL HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream
- NDC Code(s): 51824-097-01
- Packager: New World Imports, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 13, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Keep out of reach of Children
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Uses
- For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema, psoriasis, poison ivy, oak & sumac, insect bites, detergents, jewelry, seborrheic dermatitis, soap as well as for external genital, geminine and anal itching
- Other uses of this product should be only under the advice and supervision of a doctor
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Warnings
For external use only
Do not use:
For the treatment of diaper rash. Consult a doctor
if you have vaginal discharge. Consult 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 this product into the rectum by using fingers or any mechanical device or applicator
If rectal bleeding occurs, consult a doctor promptly
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.
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Directions
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 and children 12 years of age and older:
- when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
- Gently dry by patting or blotting with toliet 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 with external anal itching: consult a doctor.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAREALL HYDROCORTISONE MAXIMUM STRENGTH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-097 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE .01 g in 1 g Inactive Ingredients Ingredient Name Strength Propylene Glycol (UNII: 6DC9Q167V3) WHITE PETROLATUM (UNII: B6E5W8RQJ4) Mineral Oil (UNII: T5L8T28FGP) Cetostearyl Alcohol (UNII: 2DMT128M1S) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) Chlorocresol (UNII: 36W53O7109) Water (UNII: 059QF0KO0R) Product Characteristics Color white (White Cream) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-097-01 28 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 01/01/2024 Labeler - New World Imports, Inc (075372276)