AVEENO 1% HYDROCORTISONE ANTI-ITCH CREAM- hydrocortisone cream

Aveeno 1% Hydrocortisone Anti-Itch Cream by

Drug Labeling and Warnings

Aveeno 1% Hydrocortisone Anti-Itch Cream by is a Otc medication manufactured, distributed, or labeled by Kenvue Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Use

For the temporary relief of itching associated with minor skin irritations and rashes due to:

• eczema
• insect bites
• poison ivy, oak or sumac
• soaps and detergents
• cosmetics
• jewelry
• seborrheic dermatitis
• psoriasis
• Other uses of this product should be only under the advice and supervision of doctor

Warnings

For external use only.

Do not use

• in or near eyes
• for diaper rash; ask a doctor

Ask a doctor before use if you are using any other hydrocortisone product

Stop use and ask a doctor if

• condition worsens or if symptoms persist for more than 7 days
• symptoms last more than 7 days or clear up and occur again within a few days

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 of age and older: Apply to affected area not more than 3 to 4 times daily
• children under 2 years of age; do not use, ask a doctor

Other information

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards. Protect from Excessive Heat (40°C/104°F)

Inactive ingredients

Water, Cetearyl Alcohol, Glycerin, Isopropyl Palmitate, Ceteareth-20, Avena Sativa (Oat) Kernel Flour, Potassium Lactate, Ethylhexyl Palmitate, Cetyl Palmitate, Phenoxyethanol, Caprylyl Glycol, PEG-80 Sorbitan Laurate, Citric Acid, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Avena Sativa (Oat) Kernel Oil, Avena Sativa (Oat) Kernel Extract, Sodium Hydroxide

Questions?

866-428-3366;

Outside US, dial collect 215-273-8755 www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 28 g Tube in a Carton Label

Aveeno®

1% Hydrocortisone

ANTI-ITCH CREAM

Effectively relieves

itch from:

Eczema ● Psoriasis

Poison Ivy ● Oak ● Sumac

Insect Bites ● Detergents ● Soaps

Maximum Strength Formula

With Triple Oat, Aloe,

& Vitamin E

DERMATOLOGIST RECOMMENDED BRAND

TRIPLE OAT

net wt. 1 oz (28 g)

INGREDIENTS AND APPEARANCE

AVEENO 1% HYDROCORTISONE ANTI-ITCH CREAM 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0888
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
OATMEAL (UNII: 8PI54V663Y)
POTASSIUM LACTATE (UNII: 87V1KMK4QV)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-80 SORBITAN LAURATE (UNII: 239B50Y732)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OAT (UNII: Z6J799EAJK)
OAT KERNEL OIL (UNII: 3UVP41R77R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0888-1	1 in 1 CARTON	07/01/2024
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 Drug	M017	07/01/2024

Labeler - Kenvue Brands LLC (118772437)