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JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558
Aveeno 1% Hydrocortisone Anti-itch Cream
FDA Label NDC 69968-0888
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 1% Hydrocortisone Anti-itch Cream (NDC 69968-0888). 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.
Label Section Quick Index
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 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 persist 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 right away.
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
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. Protect from Excessive Heat (40°C/104°F)
Inactive Ingredients
Water, Cetearyl Alcohol, Glycerin, Isopropyl Palmitate, Ceteareth-20, Avena Sativa (Oat) Kernel Flour, Potassium Lactate, Ethylhexyl Palmitate, Cetyl Palmitate, Phenoxyethanol, Caprylyl Glycol, PEG-80 Sorbitan Laurate, Citric Acid, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Avena Sativa (Oat) Kernel Oil, Avena Sativa (Oat) Kernel Extract, Sodium Hydroxide
Questions?
866-428-3366;
Outside US, dial collect 215-273-8755 www.aveeno.com
Principal Display Panel - 28 G Tube In A Carton Label
Aveeno®
1% Hydrocortisone
ANTI-ITCH CREAM
Effectively relieves
itch from:
Eczema ● Psoriasis
Poison Ivy ● Oak ● Sumac
Insect Bites ● Detergents ● Soaps
Maximum Strength Formula
With Triple Oat, Aloe,
& Vitamin E
DERMATOLOGIST RECOMMENDED BRAND
TRIPLE OAT
net wt. 1 oz (28 g)
69968-0888_1 (69968 0888 1)
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