AVEENO HYDROCORTISONE ANTI ITCH- hydrocortisone cream

Aveeno Hydrocortisone Anti Itch by

Drug Labeling and Warnings

Aveeno Hydrocortisone Anti Itch by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

AVEENO HYDROCORTISONE ANTI ITCH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58232-1402
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)
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 (UNII: 6GE7Z0761K)
Oat (UNII: Z6J799EAJK)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58232-1402-1	1 in 1 CARTON	10/08/2012
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 NOT FINAL	part348	10/08/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)