DAILY MOISTURIZING- dimethicone lotion 
TopCo Associates LLC

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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Drug Facts

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 Type HUMAN OTC DRUG Item Code (Source) NDC:36800-619
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 13.13 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
OATMEAL (UNII: 8PI54V663Y)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-619-40 354 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 09/03/2010
Labeler - TopCo Associates LLC (006935977)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi-Jon 790752542 manufacture(36800-619)

Revised: 2/2013
Document Id: c1208234-3bb5-4967-aa7d-61053e954ce6
Set id: 47e54eee-70e0-4bfa-ae77-d61a6560a9e1
Version: 1
Effective Time: 20130212
 
TopCo Associates LLC