Label: CORTICOL-ALOE- hydrocortisone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 53145-430-28 - Packager: MENPER DISTRIBUTORS 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 August 9, 2021
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- ACTIVE INGREDIENT
- PURPOSE
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INDICATIONS & USAGE
Uses
- temproarily relieves itching associated with minor skin irritations, inflammation and rashes due to:
- eczema
- psoriasis
- poison ivy, oak, sumac
- insect bites
- detergents
- jewlery
- cosmetics
- soaps
- seborrheic dermatitis
- temporarily relieves extranal anal and genital itching
- other uses of this product should only be under the advice and supervision of a doctor
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WARNINGS
Warnings
For external use only.
Do not use
- in the genital area if you have a vaginal discharg. Consult a doctor.
- for the treatment of diaper rash. 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 directly into the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if
- condition worsen, 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
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DOSAGE & ADMINISTRATION
Directions
- for itchin of skin irritiation, inflammation and rashes:
- adults and children 2 years of agea and older: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: ask a doctor
- for external anal and genital itching, adults
- when practical, clean the affected area with mild soap and warm water and rinse thouroghly
- 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
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CORTICOL-ALOE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53145-430 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) SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) CALCIUM ACETATE (UNII: Y882YXF34X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) MALTODEXTRIN (UNII: 7CVR7L4A2D) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) SODIUM LAURYL SULFATE (UNII: 368GB5141J) WATER (UNII: 059QF0KO0R) WHITE PETROLATUM (UNII: B6E5W8RQJ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53145-430-28 1 in 1 PACKAGE 07/01/2019 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 07/01/2019 Labeler - MENPER DISTRIBUTORS INC. (101947166)
