FDA.reportPublic FDA data

HEALING TREE CALMING ANTI-ITCH CREAM

Manufacturer
Renu Laboratories, LLC
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:42:46

Label at a glance#

ProductHEALING TREE CALMING ANTI-ITCH
Active ingredientHYDROCORTISONE
Label structure15 sections

Storage and handling

Other information store between 20° to 25° C (68° to 77° F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

1 Percent Hydrocortisone

OTC - PURPOSE SECTION

Anti-itch Anti-inflammatory

INDICATIONS & USAGE SECTION

Uses

For the temporary relief and aid in reducing redness, itching and irritation associated with eczema, psoriasis, poison oak and ivy, bug bites, rashes, minor burns, abrasions and blemishes

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • for external genital, vaginal or anal itching
  • with other hydrocortisone product unless consulted by a doctor
  • in or near the eyes
  • for diaper rash

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding ask a health professional before use

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 right away

STATEMENT OF IDENTITY SECTION

HEALING TREE

CALMING

ANTI-ITCH CREAM

NET WT. 59 ml (2.0 fl. oz.)

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 2 years of age and older: spray affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use consult a doctor
  • to apply to face, spray into palm of hand and gently apply

STORAGE AND HANDLING SECTION

Other information

store between 20° to 25° C (68° to 77° F)

INACTIVE INGREDIENT SECTION

Aloe Barbadensis leaf juice (Aloe Vera), Arnica Montana Extract, Calendula Officinalis Extract (Calendula), Carbomer, Cetyl Alcohol,

Commiphora Myrrha Oil (Myrrh), Deionized Water, Glycerin, Glycerol Stearate,Hydrastis Canadensis Root Extract (Goldenseal),

Melaleuca Alternifolia Leaf Oil (Tea Tree), Mentha Piperita Oil (Peppermint), Olea Europaea Oil (Olive), PEG-120 Methyl Glucose

Dioleate, Persea Gratissima Oil (Avocado), Polysorbate 20, Potassium Sorbate, Simmondsia Chinensis Oil (Jojoba), Sodium

Benzoate, Symphytum Officinale Extract (Comfrey) Leaf, Triethanolamine.

OTC - QUESTIONS SECTION

Questions? call 800-376-1293

Manufactured for

Healing Tree Essentials

Yamhill, OR 97148

healingtreenaturals.com

Multi-layer Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healing Tree Anti-Itch Cream

ANTI-ITCH CREAM LABELANTI-ITCH CREAM LABEL

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-804-062025-05-14C16284748780-12cef2736-6ba5-d83d-e063-dadaa90ab31fHEALING TREE CALMING ANTI-ITCH CREAM
76348-804-062025-05-14C16284748780-12cef2736-6ba5-d83d-e063-dadaa90ab31fHEALING TREE CALMING ANTI-ITCH CREAM
76348-804-062025-01-30C16284748780-12cef2736-6ba5-d83d-e063-dadaa90ab31fHEALING TREE CALMING ANTI-ITCH CREAM
76348-804-062025-01-30C16284748780-12cef2736-6ba5-d83d-e063-dadaa90ab31fHEALING TREE CALMING ANTI-ITCH CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-804-05HEALING TREE CALMING ANTI-ITCH59 mL in 1 BOTTLE, PLASTICCREAM593
76348-804-06HEALING TREE CALMING ANTI-ITCH1 in 1 BOXCREAM13

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-80476348-804-05, 76348-804-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
GOLDENSEALZW3Z11D0JVIACT
COMFREYD05HXK6R3GIACT
TROLAMINE9O3K93S3TKIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
MYRRH OILH74221J5J4IACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
PEPPERMINT OILAV092KU4JHIACT
HYDROCORTISONEWI4X0X7BPJACTIB
JOJOBA OIL724GKU717MIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
AVOCADO OIL6VNO72PFC1IACT
OLIVE OIL6UYK2W1W1EIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYSORBATE 207T1F30V5YHIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-05-14full-release2026-06-01 01:01:02

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
HEALING TREE CALMING ANTI-ITCHHYDROCORTISONERenu Laboratories, LLCfc8bcde9-26e8-a35f-e053-6394a90a33002025-11-06WarningsExact identifier
ndc (package): 76348-804-05
ndc (package): 76348-804-06
ndc (product): 76348-804
ndc11 (package): 76348080405
ndc11 (package): 76348080406
spl id: 42f25140-568e-2798-e063-6394a90a602f
spl set id: fc8bcde9-26e8-a35f-e053-6394a90a3300

Reported adverse events (FAERS/openFDA)#

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