Aveeno Baby® Calming Comfort® Lotion

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2019-04-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:25:36

Label at a glance#

ProductAveeno Baby Calming Comfort
Active ingredientDimethicone
Label structure11 sections

Indications and uses

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

Dosage and administration

Apply as needed.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1.2%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on

OTC - DO NOT USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 532 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aveeno
Baby®

PEDIATRICIAN
Aveeno®
RECOMMENDED®

LAVENDER & VANILLA SCENTED

Calming Comfort® Lotion
with Natural Colloidal Oatmeal

Dimethicone Skin Protectant

Paraben-free, Phthalate-free

Helps Protect Delicate Skin
Moisturizes for 24 Hours

Helps Calm Babies before Bedtime
18 Fl. Oz. (532 mL)

PRINCIPAL DISPLAY PANEL - 532 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 532 mL Bottle Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-003869968-0038-8, 69968-0038-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b60da9bf-511b-4483-a677-f23698f0d6638415a33b-dc91-4757-a79d-fe629763720f2019-04-17WarningsExact identifier
spl id: b60da9bf-511b-4483-a677-f23698f0d663
spl set id: 8415a33b-dc91-4757-a79d-fe629763720f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.