MedPath

H-Psoriasis Formula

H-Psoriasis Formula

Approved
Approval ID

7c06a390-821c-4450-8515-66ece3557725

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 2025

Manufacturers
FDA

Healing Natural Oils LLC

DUNS: 113679703

Products 1

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

calendula officinalis, iris versicolor

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61077-047
Product Classification
G
Generic Name
calendula officinalis, iris versicolor
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (8)

CEDRUS ATLANTICA BARK OILInactive
Code: ZX5QRE4U60
Classification: IACT
MELALEUCA ALTERNIFOLIA LEAFInactive
Code: G43C57162K
Classification: IACT
EUROPEAN HAZELNUT OILInactive
Code: 8RQ2839AVG
Classification: IACT
WHEAT GERM OILInactive
Code: 14C97E680P
Classification: IACT
IRIS VERSICOLOR ROOTActive
Quantity: 12 [hp_C] in 11 mL
Code: X43D4L3DQC
Classification: ACTIB
ROSA MOSCHATA SEED OILInactive
Code: T031ZE559T
Classification: IACT
CALENDULA OFFICINALIS FLOWERING TOPActive
Quantity: 12 [hp_C] in 11 mL
Code: 18E7415PXQ
Classification: ACTIB
CAJUPUT OILInactive
Code: J3TO6BUQ37
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/27/2017

Healing Natural Oils

H-Psoriasis

Formula

Homeopathic

For External Use Only

047

11ml (0.37 fl. oz)

amoils.com

1

2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/4/2013

Indications:

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/4/2013

Active Ingredients:

Calendula officinalis - 12C HPUS

Iris versicolor - 12C HPUS

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/4/2013

Purpose

Calendula officinalis -12C HPUS (healing agent),
Iris versicolor -12CHPUS (psoriasis, irregular patches with shining scales)

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: 11/4/2013

Directions:

Adults and Children 4 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: 11/4/2013

Warnings:

For external use only.
Perform skin test prior to initial use.


** Do not use if pregnant or breastfeeding.**


** 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 (Cedrus atlantica wood shavings, Melaleuca alternifolia leaf-branch, Melaleuca minor leaf), Rosa mosqueta seed oil, Triticum vulgare kernel oil

DESCRIPTION SECTION

LOINC: 34089-3Updated: 12/27/2017

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

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H-Psoriasis Formula - FDA Drug Approval Details