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NDC 00093-3204-14 Moisturel 30 g/g Details

Moisturel 30 g/g

Moisturel is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Teva Pharmaceuticals USA, Inc.. The primary component is DIMETHICONE.

Product Information

NDC	00093-3204
Product ID	0093-3204_d3c2ca4e-595a-4079-a95e-90d24dcc8816
Associated GPIs	90972030004120
GCN Sequence Number	071045
GCN Sequence Number Description	dimethicone LOTION 3 % TOPICAL
HIC3	L3A
HIC3 Description	PROTECTIVES
GCN	34731
HICL Sequence Number	004794
HICL Sequence Number Description	DIMETHICONE
Brand/Generic	Brand
Proprietary Name	Moisturel
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dimethicone
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	30
Active Ingredient Units	g/g
Substance Name	DIMETHICONE
Labeler Name	Teva Pharmaceuticals USA, Inc.
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	n/a

Package

Package Images

NDC 00093-3204-14 (00093320414)

Pricing Information	N/A
NDC Package Code	0093-3204-14
Billing NDC	00093320414
Package	397 g in 1 BOTTLE (0093-3204-14)
Marketing Start Date	2018-11-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 92beaed3-073f-44ac-88e0-7059529fc9e9 Details

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

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