MedPath

H- Eczema Formula

H-Eczema Formula

Approved
Approval ID

1dca2762-cd9a-4c4c-b2aa-a7dca4b4e414

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

Healing Natural Oils

DUNS: 113679703

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

anacardium orientale, iris versicolor

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61077-019
Product Classification
G
Generic Name
anacardium orientale, iris versicolor
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (9)

CYMBOPOGON MARTINI TOPInactive
Code: 7K1N3UZ6DU
Classification: IACT
LAVANDULA ANGUSTIFOLIA FLOWERInactive
Code: 19AH1RAF4M
Classification: IACT
DAUCUS CAROTA SUBSP. SATIVUS SEEDInactive
Code: 9M6AAX381U
Classification: IACT
CHAMOMILEInactive
Code: FGL3685T2X
Classification: IACT
HELICHRYSUM ITALICUM FLOWERInactive
Code: P62Y550X24
Classification: IACT
EUROPEAN HAZELNUT OILInactive
Code: 8RQ2839AVG
Classification: IACT
SEMECARPUS ANACARDIUM JUICEActive
Quantity: 12 [hp_C] in 11 mL
Code: Y0F0BU8RDU
Classification: ACTIB
IRIS VERSICOLOR ROOTActive
Quantity: 12 [hp_C] in 11 mL
Code: X43D4L3DQC
Classification: ACTIB
ROSA MOSCHATA SEED OILInactive
Code: T031ZE559T
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/27/2025

Healing Natural Oils

H-Eczema

Formula

Homeopathic

For External Use Only

019

11ml (0.37 fl. oz)

amoils.com

1

2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/1/2013

Indications:

For the temporary relief of eczema symptoms such as dryness, itching and irritation.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/1/2013

Active Ingredients:

Anacardium orientale-12C HPUS
Iris versicolor-12C HPUS

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/1/2013

Purpose

Anacardium orientale - 12C HPUS (itching, eczema),
Iris versicolor-12C HPUS (eczema with nightly itching)

The letters ‘HPUS’ indicate that the components in this product are officially
monographed in the Homoeopathic Pharmacopoeia of the United States

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/1/2013

Directions:

Adults and Children 2 yrs and over: Wash hands before and after use.
Shake well and apply 1 or 2 drops to a cotton swab or your finger and apply directly to the affected area 3x per day.
Do not oversaturate or exceed dosage.

WARNINGS SECTION

LOINC: 34071-1Updated: 11/1/2013

Warnings:

** For external use only.**

Perform skin test prior to initial use.





** If pregnant or breastfeeding consult a doctor before use.**

Keep out of reach of children.

Keep away from eyes and mucous membranes. If swallowed get medical help
or contact a Poison Control Center right away.

Discontinue use if irritation occurs.

Consult a doctor if symptoms worsen after 7 days.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/27/2025

Inactive Ingredients:

Corylus avellana nut oil, Essential Oil Blend (Cymbopogon martinii aerial parts, Daucus carota seed, Helichrysum italicum flower,
Lavandula officinalis flower bud, Matricaria recutita flower), Rosa Mosqueta seed oil.

DESCRIPTION SECTION

LOINC: 34089-3Updated: 12/11/2017

Dist. by Healing Natural Oils 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA

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