MOISTUREL- dimethicone lotion

Moisturel by

Drug Labeling and Warnings

Moisturel by is a Otc medication manufactured, distributed, or labeled by Allergan, Inc., Teva Pharmaceuticals USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

MOISTUREL 
dimethicone lotion

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	08/22/2002	04/30/2021

Labeler - Allergan, Inc. (144796497)

Registrant - Teva Pharmaceuticals USA, Inc. (001627975)