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 ZDP

Active ingredient Purpose

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

Uses

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

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

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

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

Directions

Other information

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

Distributed by:

Winco Foods, LLC, BOISE, ID 83704

24197.1

WINCO MAXIMUM STRENGTH HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-197
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-197-281 in 1 CARTON10/12/2020
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 finalpart34810/12/2020
Labeler - WINCO FOODS, LLC (056098817)

Revised: 3/2022
Document Id: db8bc2f1-c052-30ae-e053-2995a90ac857
Set id: b1812ea3-78cc-607a-e053-2a95a90a0a10
Version: 3
Effective Time: 20220331
 
WINCO FOODS, LLC