FDA.reportPublic FDA data

Moisturel ® THERAPEUTIC LOTION Drug Facts

Manufacturer
Allergan, Inc. | Teva Pharmaceuticals USA, Inc.
Effective date
2019-05-31
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 00:23:13

Label at a glance#

ProductMoisturel
Active ingredientDIMETHICONE
Label structure7 sections

Indications and uses

temporarily protects and helps prevent chafed, chapped, cracked or windburned skin. helps treat and prevent minor skin irritation due to diaper rash. helps seal out wetness in the diaper area.

Dosage and administration

for skin protectant use apply liberally as often as needed. for diaper rash use :        • change wet diapers promptly. • cleanse the diaper area and allow to dry. • apply lotion liberally with each changing.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 3%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps prevent chafed, chapped, cracked or windburned skin.
  • helps treat and prevent minor skin irritation due to diaper rash.
  • helps seal out wetness in the diaper area.

Warnings

WARNINGS SECTION

  • For external use only.

• Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes.
  • not to be applied over puncture wounds.
  • not to be applied over infections.

Stop using this product and ask a doctor

OTC - STOP USE SECTION

  • if condition worsens or does not improve within 7 days.

Directions

DOSAGE & ADMINISTRATION SECTION

  • for skin protectant use apply liberally as often as needed.
  • for diaper rash use:        • change wet diapers promptly.
    • cleanse the diaper area and allow to dry.
    • apply lotion liberally with each changing.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Benzyl alcohol, carbomer, cetyl alcohol, glycerin, laureth-23, magnesium aluminum silicate, petrolatum, potassium sorbate, sodium hydroxide, steareth-2, water.

Manufactured by: Contract Pharmaceuticals Limited
Mississauga, Ontario, Canada L5N 6L6 for
Warner Chilcott Company, LLC
Fajardo, Puerto Rico 00738

Marketed by: Warner Chilcott (US), LLC
Rockaway, NJ 07866
1-800-521-8813

To report SUSPECTED ADVERSE REACTIONS,
contact Warner Chilcott at 1-800-521-8813 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Moisturel
Therapeutic Lotion
Net WT 8 OZ. (226 g)

PRINCIPAL DISPLAY PANEL Moisturel Therapeutic Lotion Net WT 8 OZ. (226 g)
PRINCIPAL DISPLAY PANEL Moisturel Therapeutic Lotion Net WT 8 OZ. (226 g)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0430-3100-10GM - Gram0430-3100391a93fd-9e27-4dfd-9845-a5be5f80f17612017-03-06
0430-3100-11GM - Gram0430-3100121f9430-c3a5-49f9-a317-15577aeb56a512018-01-12

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0430-31000430-3100-10, 0430-3100-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
LAURETH-23N72LMW566GIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
PETROLATUM4T6H12BN9UIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM HYDROXIDE55X04QC32IIACT
STEARETH-2V56DFE46J5IACT
WATER059QF0KO0RIACT

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
8243516d-fe81-4ce0-968f-7bb7c88ac0f2cdbe0d25-f76b-4f5f-bfe6-8d6271eecfd12019-05-31WarningsExact identifier
spl id: 8243516d-fe81-4ce0-968f-7bb7c88ac0f2
spl set id: cdbe0d25-f76b-4f5f-bfe6-8d6271eecfd1

Reported adverse events (FAERS/openFDA)#

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