AVEENO HYDROCORTISONE ANTI ITCH- hydrocortisone cream 
Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, 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

  • Temporarily relieves itching associated with minor skin irritations, inflammation 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 : 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
  • 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 immediately.

Directions

  • Apply to affected area not more than 3 to 4 times daily
  • Children under 2 years, do not use; ask a doctor

Other Information

Store at room temperature. Protect from freezing and excessive heat.

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, May contain Sodium Hydroxide

Questions?

866-4AVEENO (or 866-428-3366); Outside US, dial collect 215-273-8755 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 - 28g 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 - 28g Tube Carton
AVEENO HYDROCORTISONE ANTI ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:58232-1402
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Cetostearyl Alcohol 
Glycerin 
Polyoxyl 20 Cetostearyl Ether 
Isopropyl Myristate 
Cyclomethicone 5 
Oatmeal 
Benzyl Alcohol 
Cetyl Palmitate 
Isostearyl Neopentanoate 
Citric Acid Monohydrate 
Potassium Lactate 
PEG-40 Stearate 
Methylparaben 
Oat Kernel Oil 
.Alpha.-Tocopherol Acetate 
Aloe Vera Leaf 
Tanacetum Parthenium 
Oat 
Sodium Hydroxide 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58232-1402-11 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34810/08/2012
Labeler - Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)

Revised: 10/2012
Document Id: 10bb7671-4962-4614-a57b-eb13b295c517
Set id: abccddb8-6732-4b7f-92de-c8f535184a0c
Version: 1
Effective Time: 20121009
 
Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.