Remedy Nutrashield Lotion
FDA Label NDC 53329-157

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Remedy Nutrashield (NDC 53329-157). 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, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Dimethicone 1.0%

Purpose

Skin Protectant

Uses

  • Helps treat and prevent diaper rash caused from wetness , urine, and/or stool.
  • Temporarily protects and helps relieve chapped or cracked skin.

Warnings

For External Use Only.

Do Not Use

  • on deep or puncture wounds
  • on animal bites
  • on serious burns

When Using This Product

  • do not get into eyes

Stop Use And Ask A Doctor

  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

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

Directions

  • Apply liberally as needed.

Other Information

  • Protect from freezing. Avoid excessive heat.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate,

C12-C13 Pareth-3, C12-C13 Pareth-23, Carthamus Tinctorius Seed Oil, Cetyl Dimethicone,

Cholecalciferol, Citric Acid, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil,

Citrus Tangerina Peel Oil, Cyclopentasiloxane, Diazolidinyl Urea, Dimethiconol,

Divinyldimethicone/Dimethicone Copolymer, Glycine, Hydroxytyrosol, L-proline, L-taurine,

Methylparaben, Methylsulfonylmethane, N-acetyl-L-cysteine, Niacinamide, Olea Europaea

Fruit Oil, PEG-8, PEG/PPG-18/18 Dimethicone, Propylene Glycol, Propylparaben, Pyridoxine

HCl, Retinyl Palmitate, Sodium Chloride, Tocopherol, Vanillin, Water, Zea Mays Oil.

Package/Label Principal Display Panel

NDC: 53329-157-04

MEDLINE

REMEDY®

WITH OLIVAMINE ®

NUTRASHIELD

WITH SILICONE BLENDS

Long-lasting nourishing formula that helps prevent diaper rash, dry and cracked skin.

NON-ALLERGENIC

NON-SENSITIZING

4 fl oz (118 mL)

* Please review the disclaimer below.