Remedy Skin Repair
FDA Label NDC 53329-140

13 label sections · Submitted to the FDA by Medline Industries, Lp · 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 Skin Repair (NDC 53329-140). 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 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 1.5%

Purpose

Skin Protectant

Uses

temporarily protects and helps relieve chapped or cracked skin. Beneficial for face, hands, body and legs.

Warnings

For External Use Only.

Do Not Use

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

When Using This Product

do not get into eyes.

Stop Use And Ask A Doctor If

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 cream liberally until entire area is covered
  • apply as needed

Inactive Ingredients

aloe barbadensis leafe juice, ascorbic acid, ascorbyl palmitate, canola oil, cetyl alcohol, cholecalciferol citric acid, diazolidinyl urea, glycerin, glyceryl stearate SE, glycine, hydroxytyrosol, L-proline, L-taurine, methylparaben, methylsulfonylmethane, A-acetyl-L-cysteine, niacinamide, olea europaea (olive) fruit oil, olea europaea (olive) leaf extract, PEG-100 stearate, PEG-8, propylene glycol, propylparaben, pyridoxine HCl, retinyl palmitate, stearic acid, stearyl alcohol, tetrasodium EDTA, tocopherol, triethanolamine, water

Package Label

Package Label (53329 140)

Package Label (53329 140)

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