Label: ALRA THERAPY- allantoin lotion

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 14, 2016

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  • 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

  • WHEN USING

    WHEN USING THIS PRODUCT

    • DO NOT GET INTO EYES
  • 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
  • DO NOT USE

    DO NOT USE ON

    • DEEP OR PUNCTURE WOUNDS
    • ANIMAL BITES
    • SERIOUS BURNS
  • 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?

    CALL 1-877-265-9092

    WWW.ALRA.COM

  • PRINCIPAL DISPLAY PANEL

    Therapy Lotion with Drug Box 20150810

  • INGREDIENTS AND APPEARANCE
    ALRA THERAPY 
    allantoin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58894-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LANOLIN OIL (UNII: OVV5IIJ58F)  
    ACETYLATED LANOLIN (UNII: 2X654GD19H)  
    ISOPROPYL LINOLEATE (UNII: 4MW1E9AT4H)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58894-101-11100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/14/2016
    Labeler - NEUE COSMETIC COMPANY INC (012392107)
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