Remedy Barrier Cream Cloths Cloth
FDA Label NDC 53329-074

14 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 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, warnings, do not use on, 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.

Label Section Quick Index

Active Ingredient

Dimethicone 3.6% w/v

Purpose

Skin Protectant

Uses

  • helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness
  • help prevent and temporarily protects and helps relieve chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather

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

algae extract, allantoin, butylene glycol,
butyrospermum parkii (shea butter) extract,
C12-20 alkyl glucoside, C14-22 alcohols,
camellia sinensis (green tea) extract,
caprylic/capric triglyceride, cetyl alcohol,
citric acid, cocoglucoside, coconut alcohol,
7- dehydrocholesterol, disodium
cocoamphodiacetate, ethylene brassylate,
ethylhexylglycerin, eugenia caryophyllus
(clove) flower extract, glycerin, glycine soja
(soybean) oil, helianthus annuus
(sunflower) seed oil, hydrolyzed soy
protein, hydroxyethyl acrylate/sodium
acryloyldimethyltaurate copolymer,
isohexadecane, isopropyl myristate,
lecithin, methyldihydrojasmonate,
phenoxyethanol, phospholipids,
polysorbate 60, tocopheryl acetate, urea,
vanilla plantifolia fruit extract, water, yeast
ferment extract, zea mays (corn) oil.

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