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 (in each gram)                                                            Purpose

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

PURPOSE

Uses

• for the temporary relief of itching associated with minor skin irritations, inflammation and rashed due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis
• for temporary relief of external anal and genital itching
• other uses of this product shold only be under the advice and supervision of a doctor

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• for the treatment of diaper rash. Consult a doctor
• in the genital area if you have a vaginal discharge. Consult a doctor

WHEN USING

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

Stop use and ask a doctor if

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted 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.

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: consult 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 pattin gor blotting with toilet tissue or soft cloth before applying
• apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: consult a doctor

STORAGE AND HANDLING

Other information

• store between 20° to 25°C (68° to 77°F)
• Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients

aloe vera gel, butylated hydroxytoluene, cetanol, liquid paraffin, methylparaebn, polyoxyethylene cetylether, propylene glycol, propylparaben, retinol palmitate oil, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol, tocopherol acetate

QUESTIONS

Questions? or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4pm MST

DOSAGE & ADMINISTRATION

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WINCO MAXIMUM STRENGTH HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-280
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)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PARAFFIN (UNII: I9O0E3H2ZE)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-280-28	1 in 1 CARTON	02/16/2015
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	02/16/2015

Labeler - WinCo Foods, LLC (056098817)