MOISTUREL- dimethicone lotion

Moisturel by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 all 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

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday - Friday.

Other

Quick absorbing, long lasting Moisturel® leaves skin feeling smooth and soft. Clinically proven, this skin protectant relieves dry skin and is designed not to clog pores. Free of lanolins and parabens that can irritate sensitive skin.

PRINCIPAL DISPLAY PANEL

Moisturel®
THERAPEUTIC LOTION

Dry Sensitive Skin Formula
Effectively Heals & Moisturizes

Fragrance Free Protection

DERMATOLOGIST RECOMMENDED

NET WT 8 OZ. (226 g)

INGREDIENTS AND APPEARANCE

MOISTUREL 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0093-3204
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: 0093-3204-14	397 g in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2018
2	NDC: 0093-3204-87	226 g in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	11/12/2018

Labeler - Teva Pharmaceuticals USA, Inc. (001627975)