Daily Moisturizing Lotion
FDA Label NDC 36800-619

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Daily Moisturizing (NDC 36800-619). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 at 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, 7711 GROSS POINT ROADK,

SKOKIE 60077

QUESTIONS? 1-888-423-0139 [email protected]

619.003/619AC rev 2

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)

* Please review the disclaimer below.