Remedy Barrier Cream Cloths Cloth
FDA Label NDC 53329-074

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 Barrier Cream Cloths (NDC 53329-074). 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, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Dimethicone 3.6%

Purpose

Skin Protectant

Uses

  • Helps protect from minor skin irritations associated with perineal dermatitis
  • temporarily protects and helps relieve chapped or cracked skin
  • Helps protect from the drying effects of wind and cold weather

Do Not Use

on

  • deep or puncture wounds
  • animal bites
  • serious burns

When Using This Product

do not get into eyes

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last 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

  • Open package as designated
  • Remove fresh cloths and thoroughly cleanse soiled area as needed
  • Dispose of cloths in waste receptacle, do not flush in toilet
  • Single Patient Use only

Other Information

  • Protect from freezing, avoid excessive heat
  • Keep label tightly sealed
  • Do Not Flush
  • Cloth: made of Rayon/Polyester

Inactive Ingredients

Water, Glycerin, Squalane, Glycine Soja (Soybean) Oil, Algae Extract, Camellia Sinensis (Green Tea) Extract, Eugenia Caryophyllus (Clove) Flower Extract, Butyrospermum Parkii (Shea Butter) Extract, Lecithin, Hydrolyzed Soy Protein, Allantoin, Phospholipids, C12-20 Alkyl Clucoside, C14-22 Alcohols, Cetyl Alcohol, Disodium Cocoamphodiacetate, Caprylic/Capric Triglyceride, Citric Acid, Cocoglucoside, Coconut Alcohol, Ethylene Brassylate, Ethylexylglycerin, Butylene Glycol, Isopropyl Myristate, Methyldihydrojasmonate, Yeast Ferment Extract, Phenoxyethanol, Tocopheryl Acetate, Urea, 7- Dehydrocholesterol, Helianthus Annuus (Sunflower) Seed Oil, Zea Mays (Corn) Oil, Vanilla Planifolia Fruit Extract

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