Your browser does not support JavaScript! DAILY MOISTURIZING (DIMETHICONE) LOTION [TOPCO ASSOCIATES LLC]
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RxNorm Names

DAILY MOISTURIZING (dimethicone) lotion
[TopCo Associates LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient

Active ingredient

Dimethicone 1.3%

Purpose

Purpose

Skin Protectant

Uses

Uses helps prevent and temprarily protects chafed, chapped, cracked or windburned skin.

Warnings

Warnings

For external use only

Do not use

Do not use on deep or puncture wounds, infections, or lacerations. Consult a doctor

When using this product

Wen using this product keep out of eyes

Stop use

Stop use and ask a doctor if condition worsens or does not improve within seven days

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Directions apply liberally as often at necessary

Inactive ingredients

Inactive ingredients avena sativa (oat)kernel flour, benzyl alcohol, cetyl alcohol, distearyldimonium chloride, glycerin, isopropyl palmitate, petrolaturm, sodium chloride, water

Disclaimer

This product is not manufactured or distributed by Johnon + Johnson Consumer Products Company, distributor of Aveno Daily Moisturizing Lotion

Made in the USA with US and foreign components

Adverse Reactions

DIST. BY TOPCO ASSOCIATES LLC, 7711 GROSS POINT ROADK,

SKOKIE 60077

QUESTIONS? 1-888-423-0139 topcare@topco.com

Principal Display Panel

TopCare

TONE + TEXTURE

daily

moisturizing

body lotion

fragrance free

dermatologist tested

with natural colloidal oatmeal

relieves and protects dry skin

SKIN PROTECTANT

COMPARE TO AVEENO

12 FL OZ (354 mL)

image description

DAILY MOISTURIZING 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-619
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE13.13 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
OATMEAL 
BENZYL ALCOHOL 
CETYL ALCOHOL 
DISTEARYLDIMONIUM CHLORIDE 
GLYCERIN 
ISOPROPYL PALMITATE 
SODIUM CHLORIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:36800-619-40354 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/03/2010
Labeler - TopCo Associates LLC (006935977)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(36800-619)

Revised: 02/2013
Document Id: c1208234-3bb5-4967-aa7d-61053e954ce6
Set id: 47e54eee-70e0-4bfa-ae77-d61a6560a9e1
Version: 1
Effective Time: 20130212
 
TopCo Associates LLC

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