FDA.reportPublic FDA data

Calm and Heal Melting Balm

Manufacturer
The Honest Company, Inc.
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:04:59

Label at a glance#

ProductCalm and Heal Melting Balm
Active ingredientALLANTOIN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Allantoin 0.5%

OTC - PURPOSE SECTION

Purpose skin protectant

INDICATIONS & USAGE SECTION

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 SECTION

Warnings For external use only

OTC - WHEN USING SECTION

When using this product do not get into eyes.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

cartoncarton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69366-505-232023-12-19C16284748780-10191ceaa-640c-198a-e063-dbdaa90aec3eHonest Calm & Heal Melting Balm
69366-505-282023-12-19C16284748780-10191ceaa-640c-198a-e063-dbdaa90aec3eHonest Calm & Heal Melting Balm
69366-505-232023-07-28C16284748780-10191ceaa-640c-198a-e063-dbdaa90aec3eHonest Calm & Heal Melting Balm
69366-505-282023-07-28C16284748780-10191ceaa-640c-198a-e063-dbdaa90aec3eHonest Calm & Heal Melting Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69366-505-23Calm and Heal Melting Balm1 in 1 CARTONCREAM14
69366-505-23Calm and Heal Melting Balm50 g in 1 JARCREAM504
69366-505-28Calm and Heal Melting Balm1 in 1 CARTONCREAM14
69366-505-28Calm and Heal Melting Balm15 g in 1 JARCREAM154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69366-505CALM AND HEAL MELTING BALM (ALLANTOIN) CREAM [THE HONEST COMPANY, INC.]4Current NDC, Legacy NDC, 4 package rows20231220_b08a1bd6-986d-9520-e053-2995a90a865e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69366-50569366-505-23, 69366-505-28

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYGLYCERIN-6M51422LRAMIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
WATER059QF0KO0RIACT
SUNFLOWER OIL3W1JG795YIIACT
RICE BRANR60QEP13ICIACT
SOY STEROLPL360EPO9JIACT
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
SODIUM ACETYLATED HYALURONATEWN66R7GL93IACT
MALTODEXTRIN7CVR7L4A2DIACT
ISOSTEARYL HYDROXYSTEARATEF7540880P0IACT
TOCOPHEROLR0ZB2556P8IACT
OPHIOPOGON JAPONICUS ROOT90PS6JV9GZIACT
ASCORBYL PALMITATEQN83US2B0NIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
ALLANTOIN344S277G0ZACTIB
PROPANEDIOL5965N8W85TIACT
GLYCERINPDC6A3C0OXIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ISOSTEARYL ALCOHOLQ613OCQ44YIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
LINOLEIC ACID9KJL21T0QJIACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
HYALURONATE SODIUMYSE9PPT4THIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calm and Heal Melting BalmALLANTOINThe Honest Company, Inc.b08a1bd6-986d-9520-e053-2995a90a865e2023-12-19WarningsExact identifier
ndc (package): 69366-505-23
ndc (package): 69366-505-28
ndc (product): 69366-505
ndc11 (package): 69366050528
ndc11 (package): 69366050523
spl id: eea2ae69-c25a-a9e0-e053-2a95a90a144b
spl set id: b08a1bd6-986d-9520-e053-2995a90a865e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.