WINCO MAXIMUM STRENGTH HYDROCORTISONE- hydrocortisone cream 
WinCo Foods, LLC

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.

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Winco Hydrocortisone Plus Cream 1oz 24197, 2019

Active ingredient (in each gram)                                                            Purpose

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

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

For external use only

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

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

Other information

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

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

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

MADE IN KOREA

image description

WINCO MAXIMUM STRENGTH HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-280
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-280-281 in 1 CARTON02/16/2015
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/16/201505/12/2020
Labeler - WinCo Foods, LLC (056098817)

Revised: 12/2021
 
WinCo Foods, LLC