WINCO MAXIMUM STRENGTH HYDROCORTISONE- hydrocortisone cream

Winco Maximum Strength Hydrocortisone by

Drug Labeling and Warnings

Winco Maximum Strength Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by WINCO FOODS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Hydrocortisone 1%........................................Anti-itch

PURPOSE

Uses

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema
• psoriasis
• jewelry
• insect bites
• soaps
• cosmetics
• detergents
• seborrheic dermatitis
• poison ivy, oak, sumac
• temporarily relieves external 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

Do not use

• in the genital area if you have a vaginal discharge. Consult a doctor
• for the treatment of diaper rash. Consult a doctor.
• more than directed unless directed by a doctor

WHEN USING

When using this product

• avoid contact with eyes
• do not put directly into the rectum by using fingers or any mechanical device or applicator

STOP USE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE

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: 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

STORAGE AND HANDLING

Other information

• store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

.alpha.-tocopherol acetate, aole vera leaf, aluminium sulfate octadecahydrate, calcium acetate monohydrate, cetostearyl alcohol, cetyl alcohol, corn oil, dextrin, glycerin, isopropyl palmitate, light mineral oil, maltodextrin, methylparaben, petrolatum, propylene glycol, propylparaben, purified water, sodium cetostearyl sulfate, sodium lauryl sulfate, vitamin a palmitate, white wax

DOSAGE & ADMINISTRATION

Distributed by:

Winco Foods, LLC, BOISE, ID 83704

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WINCO MAXIMUM STRENGTH HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-197
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WHITE WAX (UNII: 7G1J5DA97F)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINIUM SULFATE OCTADECAHYDRATE (UNII: TCS9L00G8F)
CALCIUM ACETATE MONOHYDRATE (UNII: 7ZA48GIM5H)
CORN OIL (UNII: 8470G57WFM)
ICODEXTRIN (UNII: 2NX48Z0A9G)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-197-28	1 in 1 CARTON	10/12/2020
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	10/12/2020

Labeler - WINCO FOODS, LLC (056098817)