Aveeno Eczema Therapy Itch Relief Balm Cream
FDA Label NDC 69968-0419

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 Eczema Therapy Itch Relief Balm (NDC 69968-0419). 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, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Active Ingredient

  • Colloidal Oatmeal 1 %

Purpose

Skin Protectant

Uses

  • Temporarily protects and helps relieve minor skin irritation and itching due to:
    • eczema
    • rashes

Warnings

  • For external use only

Otc - When Using

  • When using this product
    • do not get into eyes.

Otc - Stop Use

  • Stop use and ask a doctor if:
    • condition worsens
    • 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

  • Apply as needed

Other Information

  • Do not use if quality seal is broken or missing
  • Protect from excessive heat (40°C/104°F)

Inactive Ingredients

Glycerin, Water, Cetearyl Alcohol, Isocetyl Alcohol, Dimethicone, Cetyl Alcohol, Benzyl Alcohol, Ethylhexylglycerin, Sodium Cetearyl Sulfate, Benzoic Acid, Stearic Acid, Dipotassium Phosphate, Potassium Phosphate, p-Anisic Acid, Caprylic/Capric Triglyceride, Sodium Hydroxide, Avena Sativa (Oat) Kernel Oil, Ceramide NP, Citric Acid, Avena Sativa (Oat) Kernel Extract

Questions?

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

Principal Display Panel - 312 G Jar Label

 NEW LOOK
SAME GREAT FORMULA
Aveeno®
Eczema
Therapy

itch relief balm
colloidal oatmeal • skin protectant cream

Soothes Itchy Skin

Immediate itch relief that
lasts on eczema- prone skin
Steroid-free • fragrance-free

ACCEPTED
e
NATIONALECZEMA.ORG

 NATIONAL
 ECZEMA
 ASSOCIATION

with
COLLOIDAL
OATMEAL
& CERAMIDE

 net wt. 11 oz (312 g)

Principal Display Panel (312 g Jar Label)

Principal Display Panel (312 g Jar Label)

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