Aveeno Hydrocortisone Anti-itch Cream
FDA Label NDC 69968-0511

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Aveeno Hydrocortisone Anti-itch (NDC 69968-0511). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, do not use, otc - ask doctor, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Other

Drug Facts

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

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

Otc - Ask 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

Otc - Keep Out Of Reach Of Children

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

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)

* Please review the disclaimer below.