ANTI ITCH- hydrocortisone cream 
Weeks & Leo Co., Inc.

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Hydrocortisone with oats

Active Ingredient

Hydrocortisone 1 %

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

eczema

seborrheic dermatitis

psoriasis

insect bites

poison ivy, poison oak, and poison sumac

cosmetics

jewelry

detergents

soaps

temporarily relieves external anal and genital itching

other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

When using this product

do not get into the eyes

Do not use

for the treatment of diaper rash. Ask a doctor.

Stop us and ask doctor if

condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.

Keep out of reach of children

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

Directions

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

Other information

store at 20 °C to 25 °C (68 °F to 77 °F)

Inactive ingredient

aloe barbadensis (aloe vera) leaf juice, anhydrous citric acid, avena sativa (oat) kernel extract, avena sativa (oat) kernel flour, avena sativa (oat) kernel oil, benzyl alcohol, ceteareth-20, cetostearyl alcohol, cetyl palmitate, cyclopentasiloxane, dimethicone/vinyltrimethylsiloxysilicate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben,
polyoxyl 40 stearate, potassium lactate, purified water, sodium hydroxide, vitamin E

Purpose

Anti-Itch

Content of labeling

Principal Display Panel

Compare to active ingredient in Aveeno 1% Hydrocortisone Anti-Itch Cream with triple Oats

Helps relive severe itch from

Eczema, poison Ivy, Psoriasis, insect bites, seborrheic dermatitis, detergents & soaps Poison oak & sumac

Hydrocortisone Cream 1% with Oats, Aloe & vitamin E

ANTI ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11383-292
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POTASSIUM LACTATE (UNII: 87V1KMK4QV)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
VINYLTRIMETHYLSILYLOXY SILICATE (UNII: XZ65AY5QAK)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11383-292-0128 g in 1 TUBE; Type 0: Not a Combination Product02/10/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/10/2013
Labeler - Weeks & Leo Co., Inc. (005290028)
Registrant - Weeks & Leo Co., Inc. (005290028)
Establishment
NameAddressID/FEIBusiness Operations
Weeks & Leo Co., Inc.005290028manufacture(11383-292)

Revised: 12/2023
Document Id: 0c58634f-2474-3637-e063-6394a90a0704
Set id: 0c58b750-d3a6-5ed1-e063-6294a90a4321
Version: 1
Effective Time: 20231212
 
Weeks & Leo Co., Inc.