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Moisturel

Medically reviewed on October 13, 2016

Dosage form: lotion
Ingredients: DIMETHICONE 30g in 1g
Labeler: Allergan, Inc.
NDC Code: 0430-3100

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0430-3100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE30 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CARBOXYPOLYMETHYLENE 
CETYL ALCOHOL 
GLYCERIN 
LAURETH-23 
MAGNESIUM ALUMINUM SILICATE 
PETROLATUM 
POTASSIUM SORBATE 
SODIUM HYDROXIDE 
STEARETH-2 
WATER 
Packaging
#Item CodePackage Description
1NDC:0430-3100-10226 g in 1 BOTTLE
2NDC:0430-3100-11397 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34708/22/2002
Labeler - Allergan, Inc. (144796497)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

 
Allergan, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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