Aveeno Baby Eczema Therapy Nighttime Balm Cream
FDA Label NDC 69968-0540

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 Baby Eczema Therapy Nighttime Balm (NDC 69968-0540). 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, when using this product, stop use and ask a doctor if, 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.

When Using This Product

  • do not get into eyes.

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 Or Comments?

Call toll-free 866-4-AVEENO (866-428-3366) or 215-273-8755 (collect) www.aveeno.com

Principal Display Panel - 312 G Jar Label

Aveeno
Baby®

Eczema
Therapy

NIGHTTIME BALM
colloidal oatmeal • skin protectant cream

Steroid-free • Fragrance-free • Paraben-free
Phthalate-free • Hypoallergenic
Specially formulated to provide immediate
and long-lasting moisture through the night

NET WT. 11 OZ (312 g)

ACCEPTED
e
NATIONALECZEMA.ORG

NATIONAL
ECZEMA
ASSOCIATION

PEDIATRICIAN
RECOMMENDED
BRAND

Principal Display Panel (312 g Jar Label)

Principal Display Panel (312 g Jar Label)

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