Aveeno Baby Calming Comfort Lotion
FDA Label NDC 69968-0629

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 Calming Comfort (NDC 69968-0629). 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, do not use on, 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

Dimethicone 1.2%

Purpose

Skin protectant

Uses

  • Temporarily protects and helps relieve chafed, chapped, or cracked skin
  • Helps prevent and protect from the drying effects of wind and cold weather.

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.

Do Not Use On

  • Deep or puncture wounds
  • Animal bites
  • Serious burns.

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

  • Store at room temperature.
  • Remove quality seal. Do not use if quality seal is broken.

Inactive Ingredients

Water , Glycerin, Distearyldimonium Chloride ,Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Fragrance, Sodium Chloride

Questions?

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

Principal Display Panel - 532 Ml Bottle Label

RECOMMENDED BY
PEDIATRICIANS
& DERMATOLOGIST
Aveeno®
New
Look

baby
New Gentle
Fragrance
calming comfort®
lotion
natural oatmeal
+ lavender scent
dimethicone skin protectant
moisturizes baby's
skin for 24hrs
helps calm baby
before bedtime
lavender &
vanilla scented
18 FL OZ (532 mL)

Principal Display Panel (532 mL Bottle Label)

Principal Display Panel (532 mL Bottle Label)

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