FDA.reportPublic FDA data

Mountain Falls 496.000-496AA Daily Baby Lotion

Manufacturer
Vi-Jon, LLC
Effective date
2022-04-18
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
legacy-cache
Hydrated at
2026-08-01 21:52:03

Label at a glance#

ProductDaily Baby
Active ingredientDIMETHICONE
Label structure13 sections

Indications and uses

helps prevent and temporarily protects chapped or cracked skin helps protect from the drying effects of wind and cold weather

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethcone 1.2%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • helps prevent and temporarily protects chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

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 in a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply as needed

Other information

SPL UNCLASSIFIED SECTION

store between 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, Avea sativa (oat) kernel flour, benzyl alcohol, sodium chloride, sodium hydroxide

SPL UNCLASSIFIED SECTION

Baby lotion

skin protectant

*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Aveeno Baby Daily Moisture Lotion.

Manufactured by: Vi-Jon, Inc., St. Louis, MO 63114

Questions or Comments? 1-888-593-0593

Made in the USA with US and foreign parts.

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mountain falls

*Compare to Aveeno

hypoallergenic

paraben free

helps heal and protect baby's skin

fragrance free

Baby Lotion

skin protectant with colloidial oatmeal

18 FL OZ (532 mL)

image descriptionimage description

DailyMed REMS / Drug Safety Documents#

REMS documents for this label

REMS document, Relation, Version table
REMS documentRelationVersionEffectiveSponsorSource
Risk Evaluation and Mitigation Strategy (REMS) Document Vigabatrin Shared System REMSSPL related document102026-03-18United BioSource LLC (UBC)20260509_f7d654cd-14c7-4909-8bfd-0914892fb7fb.zip!305fbe82-1ea4-4be2-8c16-8822eb55260f.xml

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
0869-04960869-0496-34, 0869-0496-32, 0869-0496-44

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
GLYCERINPDC6A3C0OXIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PETROLATUM4T6H12BN9UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETYL ALCOHOL936JST6JCNIACT
oatmeal8PI54V663YIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML · Source PDF

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
10a84be1-1864-96cf-e063-6294a90a984ba5c919e2-7acc-40fe-9f5b-9fc3b2bcf5ad2024-02-05WarningsExact identifier
spl set id: a5c919e2-7acc-40fe-9f5b-9fc3b2bcf5ad

Reported adverse events (FAERS/openFDA)#

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