AVEENO HYDROCORTISONE ANTI ITCH- hydrocortisone cream
Johnson & Johnson Consumer Inc.

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.

----------

Aveeno 1% Hydrocortisone Anti-Itch Cream

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses

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

eczema
soaps and detergents
insect bites
poison ivy, oak or sumac
cosmetics
seborrheic dermatitits
psoriasis
jewelry
Other uses of this product: ask a doctor

Warnings

For external use only

Do not use

in or near the 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 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 immediately.

Directions

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

Protect from excessive heat (40°C/100°F).

Inactive ingredients

Water, Cetearyl Alcohol, Glycerin, Ceteareth-20, Isopropyl Myristate, Cyclopentasiloxane, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Cetyl Palmitate, Isostearyl Neopentanoate, Citric Acid, Dimethicone/Vinyltrimethylsiloxysilicate Crosspolymer, Potassium Lactate, Dimethyl MEA, PEG-40 Stearate, Methylparaben, Avena Sativa (Oat) Kernel Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Chrysanthemum Parthenium (Feverfew) Extract, Avena Sativa (Oat) Kernel Extract, Sodium Hydroxide

Questions?

866-4AVEENO (or 866-428-3366) or 215-273-8755 (collect) www.aveeno.com

Distributed in the US by:
JOHNSON & JOHNSON
CONSUMER PRODUCTS COMPANY
Division of Johnson & Johnson
Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Dermatologist Recommended
Aveeno®
ACTIVE NATURALS®

1% Hydrocortisone
ANTI-ITCH CREAM

Effectively relieves itch from:
Eczema • Psoriasis
Poison Ivy • Oak • Sumac
Insect Bites • Detergents • Soaps

Maximum Strength Formula
Specially formulated for longer-lasting relief

With Triple Oat Complex, Aloe, & Vitamin E

NET WT. 1 OZ. (28g)

Principal Display Panel - 28 g Tube Carton

AVEENO HYDROCORTISONE ANTI ITCH
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58232-1402
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glycerin (UNII: PDC6A3C0OX)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Oatmeal (UNII: 8PI54V663Y)
Benzyl Alcohol (UNII: LKG8494WBH)
Cetyl Palmitate (UNII: 5ZA2S6B08X)
Isostearyl Neopentanoate (UNII: 411THY156Q)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Potassium Lactate (UNII: 87V1KMK4QV)
PEG-40 Stearate (UNII: ECU18C66Q7)
Methylparaben (UNII: A2I8C7HI9T)
Oat Kernel Oil (UNII: 3UVP41R77R)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K)
Oat (UNII: Z6J799EAJK)
Sodium Hydroxide (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58232-1402-1	1 in 1 CARTON	10/08/2012	11/01/2020
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	10/08/2012	11/01/2020

Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 6/2020

Document Id: f9a7ae09-faa7-4fc9-91aa-5ca0e28ea622

Set id: abccddb8-6732-4b7f-92de-c8f535184a0c

Version: 5

Effective Time: 20200611

Johnson & Johnson Consumer Inc.