Walgreens Moisture Barrier Cream
FDA Label NDC 0363-3680

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Walgreens Moisture Barrier (NDC 0363-3680). 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 otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, indications & usage, storage and handling, inactive ingredient, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredients                                                        Purpose

Menthol 0.44%......................................................... External analgesic/ Anti-itch

Zinc Oxide 20.6%..................................................... Skin protectant/ Anorectal astringent

Otc - Purpose

Uses

A moisture barrier that prevents & helps heal skin irritations from:

  • urine
  • diarrhea
  • perspiration
  • fistula drainage
  • feeding tube site leakage
  • wound drainage (peri-wound skin)
  • minor burns
  • cuts
  • scrapes
  • itching

Warnings

Warnings:

For external use only

  • Not for deep or puncture wounds
  • Avoid contact with eyes

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children

  • In case of accidental ingestion contact a physican or poison control center immediately
  • If condition worsens or does not improve within 7 days, consult a doctor

Indications & Usage

Directions

Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of the ointment to irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Storage And Handling

Other information

Store between 15°-30° (59°-86°F)

Inactive Ingredient

Inactive ingredients

butylated hydroxytoluene, calamine, cetyl esters, glycerin, lanolin, phenol sodium, bicarbonate, thymol, white petrolatum

Dosage & Administration

DISTRIBUTED BY:

WALGREEN CO.

200 WILMOT RD.

DEERFIELD, IL 60015

MADE IN KOREA

Package Label.Principal Display Panel

Image Description (368023.2)

Image Description (368023.2)

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