CORTICOL-ALOE- hydrocortisone cream

Corticol-Aloe by

Drug Labeling and Warnings

Corticol-Aloe by is a Otc medication manufactured, distributed, or labeled by MENPER DISTRIBUTORS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Hydrocortisone 1%

PURPOSE

Purpose

Anti-itch

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

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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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

Inactive ingredients

aloe barbadensis leaf juice, beeswax, clacium acetate, cetearyl alcohol, glycerin, maltodextrin, mehtylparaben, mineral oil, propylparaben, sodium cetearyl sulfate, sodium lauryl sulfate, water, white petrolatum

QUESTIONS

Questions

www.menperdistributors.com or 1-800-560-5223 M-F 9 am - 4 pm EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORTICOL-ALOE 
hydrocortisone cream

Product 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)