Label: CALM AND HEAL MELTING BALM- allantoin cream

  • NDC Code(s): 69366-505-23, 69366-505-28
  • Packager: The Honest Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient Allantoin 0.5%

  • PURPOSE

    Purpose skin protectant

  • INDICATIONS & USAGE

    Uses

    • Temporarily protects minor:

    •cuts

    •scrapes

    •burns

    • Helps prevent and helps relieve chapped or cracked skin
    • Helps prevent and protect from the drying effects of wind and cold weather
  • WARNINGS

    Warnings For external use only

    When using this product do not get into eyes.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions Apply as needed. Warm up product in hands to transform the rich cream to a silky balm, then gently massage a thin layer onto skin.

  • SPL UNCLASSIFIED SECTION

    Other information: Store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients Water (Aqua/Eau),Helianthus Annuus (Sunflower) Seed Oil,Caprylic/Capric Triglyceride,Oryza Sativa (Rice) Bran Wax,Polyhydroxystearic Acid, Polyglyceryl-6 Polyhydroxystearate, Polyglyceryl-6 Polyricinoleate, Magnesium Sulfate,Propanediol,Glycerin, Butyrospermum Parkii (Shea) Butter, Phytosterols,Phospholipids, Linoleic Acid, Hydrolyzed Sodium Hyaluronate, Sodium Acetylated Hyaluronate, Ophiopogon Japonicus Root Extract, Maltodextrin, Polyglycerin-6, Trisodium Ethylenediamine Disuccinate, Isostearyl Hydroxystearate, Hydroxyacetophenone, 1,2-Hexanediol, Caprylyl Glycol,Isostearyl Alcohol,Tocopherol, Ascorbyl Palmitate

  • SPL UNCLASSIFIED SECTION

    HONEST BEAUTY ®

    CALM & HEAL MELTING BALM

    designed for dry skin

    with calming phyto-blemd™ + allantoin

    + mondo grass root extract

    ©2021 Dist. by

    The Honest Company, Inc.

    Los Angeles, CA 90094

    Net Wt. 1.7 oz. / 50 g

    Net Wt. 0.5 oz 15 g

  • PRINCIPAL DISPLAY PANEL

    label

    carton

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    CALM AND HEAL MELTING BALM 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69366-505
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYGLYCERIN-6 (UNII: M51422LRAM)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    WATER (UNII: 059QF0KO0R)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    RICE BRAN (UNII: R60QEP13IC)  
    SOY STEROL (UNII: PL360EPO9J)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ISOSTEARYL HYDROXYSTEARATE (UNII: F7540880P0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69366-505-231 in 1 CARTON09/29/2020
    150 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:69366-505-281 in 1 CARTON09/01/2021
    215 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/29/2020
    Labeler - The Honest Company, Inc. (969962757)
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