Label: CAREALL HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream
- NDC Code(s): 51824-050-01, 51824-050-09, 51824-050-14
- Packager: New World Imports, Inc
- 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 5, 2022
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- Official Label (Printer Friendly)
- Active Ingredient
- Keep out of reach of Children
Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, detergents, jewelry, seborrheic dermatitis, soaps, external itching and anal itching.
Other uses of this product should be only under the advice and supervision of a doctor
For external use only
Do not use:
For the treatment of diaper rash. Ask a doctor
In the genital if you have a 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
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
for itching of skin irritation, inflammation and rashes:
- Adults and children 2 years of age and olderapply 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:
- adults: 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: ask a doctor.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
CAREALL HYDROCORTISONE MAXIMUM STRENGTH
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocortisone Acetate (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone Acetate 1 g in 1 g Inactive Ingredients Ingredient Name Strength Propylene Glycol (UNII: 6DC9Q167V3) Petrolatum (UNII: 4T6H12BN9U) Mineral Oil (UNII: T5L8T28FGP) Cetostearyl Alcohol (UNII: 2DMT128M1S) CETETH-20 (UNII: I835H2IHHX) 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:51824-050-01 28 g in 1 TUBE; Type 0: Not a Combination Product 04/27/2016 2 NDC:51824-050-14 144 in 1 CONTAINER 05/01/2022 2 NDC:51824-050-09 .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 03/11/2016 Labeler - New World Imports, Inc (075372276)