Label: ALRA THERAPY- allantoin lotion

  • NDC Code(s): 58894-101-11
  • Packager: NEUE COSMETIC COMPANY INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    ALLANTOIN 0.5%

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  • PURPOSE

    SKIN PROTECTANT

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  • USES

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

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  • WARNINGS

    FOR EXTERNAL USE ONLY

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  • WHEN USING

    WHEN USING THIS PRODUCT

    • DO NOT GET INTO EYES
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  • 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
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  • DO NOT USE

    DO NOT USE ON

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

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  • DIRECTIONS

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

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  • 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

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  • QUESTIONS OR COMMENTS?

    CALL 1-877-265-9092

    WWW.ALRA.COM

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  • INGREDIENTS AND APPEARANCE
    ALRA THERAPY 
    allantoin lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58894-101
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58894-101-11 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/14/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 06/14/2016
    Labeler - NEUE COSMETIC COMPANY INC (012392107)
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