OTC Medication Information: Daily Moisturizing

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.

Active ingredient

Dimethicone 1.3%

Purpose

Skin Protectant

Uses

  • helps prevent and temprarily protects chafed, chapped, cracked or cracked skin
  • helps protect from the drying effects of wind and cold weather

Warnings

For external use only

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

keep out of eyes

Stop use and ask a doctor if

condition worsens or does not improve within seven days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

apply liberally as often as necessary

Inactive ingredients

water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, Avena sativa (oat) kernel flour, benzyl alcohol, sodium chloride

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

ELK GROVE VILLAGE, IL 60007

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

www.topccarebrand.com

619.003/619AC rev 2

principal display panel

TOPCARE

beauty

DAILY

MOISTURIZING

LOTION

Dimethicone Skin Protectant

Compare to AVEENO

With natural colloidal oatmeal

Dermatologist tested

Fragrance

Free

18 FL OZ (1 PT 2 FL OZ) 532 mL

image descriptionimage 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 (DIMETHICONE) DIMETHICONE 13.13 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
DISTEARYLDIMONIUM CHLORIDE
PETROLATUM
ISOPROPYL PALMITATE
CETYL ALCOHOL
OATMEAL
BENZYL ALCOHOL
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-619-44 532 mL in 1 BOTTLE, PUMP None
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 Operations
Vi-Jon 790752542 manufacture (36800-619)

Revised: 04/2020 TopCo Associates LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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