MOISTUREL- dimethicone lotion
Allergan, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Moisturel® THERAPEUTIC LOTION
Drug Facts

Active Ingredient

Dimethicone 3%

Purpose

Skin Protectant

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.

Warnings

For external use only.

• Keep out of reach of children.

When using this product

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

if condition worsens or does not improve within 7 days.

Directions

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:

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

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

MOISTUREL
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0430-3100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	30 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
LAURETH-23 (UNII: N72LMW566G)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PETROLATUM (UNII: 4T6H12BN9U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARETH-2 (UNII: V56DFE46J5)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0430-3100-10	226 g in 1 BOTTLE; Type 0: Not a Combination Product	08/22/2002	09/30/2020
2	NDC:0430-3100-11	397 g in 1 BOTTLE; Type 0: Not a Combination Product	08/22/2002	04/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	08/22/2002	04/30/2021

Labeler - Allergan, Inc. (144796497)

Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 5/2019

Document Id: 8243516d-fe81-4ce0-968f-7bb7c88ac0f2

Set id: cdbe0d25-f76b-4f5f-bfe6-8d6271eecfd1

Version: 6

Effective Time: 20190531

Allergan, Inc.

Moisturel® THERAPEUTIC LOTION Drug Facts