Alra Therapy
FDA Label NDC 58894-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Neue Cosmetic Company Inc for the product Alra Therapy (NDC 58894-101). 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 ingredients, purpose, uses, warnings, otc - when using, otc - stop use, otc - do not use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

ALLANTOIN 0.5%

Purpose

SKIN PROTECTANT

Uses

HELPS PREVENT AND RELIEVE SKIN IRRITATION, REDNESS AND PAIN, SUCH AS SYMPTOMS CAUSED BY RADIATION THERAPY OR DERMATOLOGICAL PROCEDURES.

Warnings

FOR EXTERNAL USE ONLY

Otc - When Using

WHEN USING THIS PRODUCT

  • DO NOT GET INTO EYES

Otc - Stop Use

STOP USE AND ASK A DOCTOR IF

  • CONDITIONS WORSEN
  • SYMPTOMS LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS

Otc - Do Not Use

DO NOT USE ON

  • DEEP OR PUNCTURE WOUNDS
  • ANIMAL BITES
  • SERIOUS BURNS

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Directions

APPLY A SMALL AMOUNT OF ALRA THERAPY LOTION TO THE AFFECTED AREA TWICE DAILY OR AS DIRECTED BY PHYSICIAN.

Inactive Ingredients

100% ALOE VERA (NO WATER), LANOLIN OIL, ACETYLATED LANOLIN, ISOPROPYL LANOLATE, GLYCEROL STEARATE, PEG-100 STEARATE, SOLUBLE COLLAGEN, STEARIC ACID, CETYL ALCOHOL, STEARYL ALCOHOL, TOCOPHERYL ACETATE, METHYLPROPANEDIOL, TETRASODIUM EDTA, CAPRYLYL GLYCOL, POTASSIUM SORBATE, PHENYLPROPANOL, TRIETHANOLAMINE

Questions Or Comments?

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