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

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 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 persists 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

• 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

Protect from Excessive Heat (40°c/104°F)

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.

Inactive ingredients

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

Questions?

call toll-free 866-428-3366 or 215-273-8755 (collect) www.aveeno.com

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Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Dermatologist Recommended
Aveeno®
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. (28 g)

INGREDIENTS AND APPEARANCE

AVEENO HYDROCORTISONE ANTI-ITCH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0511
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)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
OATMEAL (UNII: 8PI54V663Y)
Cetyl Palmitate (UNII: 5ZA2S6B08X)
Isostearyl Neopentanoate (UNII: 411THY156Q)
Benzyl Alcohol (UNII: LKG8494WBH)
Potassium Lactate (UNII: 87V1KMK4QV)
Methylparaben (UNII: A2I8C7HI9T)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Oat Kernel Oil (UNII: 3UVP41R77R)
Oat (UNII: Z6J799EAJK)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Sodium Hydroxide (UNII: 55X04QC32I)
PEG-40 Stearate (UNII: ECU18C66Q7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0511-1	1 in 1 CARTON	03/01/2019
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	03/01/2019

Labeler - Johnson & Johnson Consumer Inc. (002347102)