MOISTUREL- dimethicone lotion
Teva Pharmaceuticals USA, 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 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)

MOISTUREL
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0093-3204
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:0093-3204-14	397 g in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2018	08/25/2023
2	NDC:0093-3204-87	226 g in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020	08/25/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	11/12/2018	08/25/2023

Labeler - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 11/2021

Document Id: d3c2ca4e-595a-4079-a95e-90d24dcc8816

Set id: 92beaed3-073f-44ac-88e0-7059529fc9e9

Version: 5

Effective Time: 20211116

Teva Pharmaceuticals USA, Inc.