Aloe Vesta Protective Barrier
FDA Label NDC 43553-4134

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Convatec, Inc. for the product Aloe Vesta Protective Barrier (NDC 43553-4134). 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 see 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

Petrolatum 36%

Purpose

Skin Protectant

Uses

  • Temporarily protects minor
  • cuts
  • scrapes
  • burns.

    • Temporarily protects and helps relieve chapped or cracked skin.
    • Helps treat and prevent diaper rash.
    • Protects minor skin irritation associated with diaper rash and helps seal out wetness.

Warnings

For external use only.

Do Not Use On

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

When Using This Product

  • avoid spraying in eyes
  • do not intentionally inhale.

Stop Use And See A Doctor If

condition lasts more than 7 days.

Keep Out Of Reach Of Children.

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

Flammable

Contents under pressure

  • Keep away from heat, sparks, and open flame.
  • Do not puncture or incinerate container.
  • Exposure to temperatures above 120oF may cause bursting.

Directions

Do not overspray.  Shake before use.  Hold can 4-6 inches from skin and spray.

For skin protection

  • Apply a thin continuous coating as needed.
    • For diaper rash

    • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.  Apply as needed, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

Other Information

Store at 15oC - 30oC (59oF - 86oF).

Inactive Ingredients

Hexamethyldisiloxane, Softisan 649, Mineral Oil, Aloe Extract.

Principal Display Panel


Aloe Vesta Protective Barrier Spray Label (C83c8a0d A979 4024 9f02 01392449ecbc 01)

Aloe Vesta Protective Barrier Spray Label (C83c8a0d A979 4024 9f02 01392449ecbc 01)


NDC 43553-4134-1

ConvaTec

ALOE VESTATM

Protective Barrier Spray 3

PROTECT

SKIN PROTECTANT

Shake before use

Soothes irritated skin

For weepy, denuded skin

Apply from any angle

Easy to remove

NET WT. 2.1 oz.(60g)

CSX1876A  Case Order No. 413401

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