FDA.reportPublic FDA data

TopicSkin

Manufacturer
ZBM Natural Medicine Ltd. | Emilia Cosmetics Ltd
Effective date
2014-11-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:06:08

Label at a glance#

ProductTopicSkin
Active ingredientHYDRASTIS CANADENSIS WHOLE, MENTHA PIPERITA, MELISSA OFFICINALIS
Label structure12 sections

Indications and uses

Helps relieve red, dry and irritated skin. Helps clear away unpleasant reddish patches. Helps restore the skin to its natural state.

Dosage and administration

When using product for the first time, apply to a small area on the skin and wait for about 10 minutes. If there is no irritation, you may continue use. For adults and children 6 months of age and over For best results, apply the cream three times a day to clean skin.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydrastis canadensis L. 6X HPUS

Mentha piperita L. 6X HPUS

Melissa officinalis L. 6X HPUS

Purpose

OTC - PURPOSE SECTION

Red, dry skin relief

Natural skin state restoration

Reddish skin color reduction Clearing of unpleasant patches

Uses

INDICATIONS & USAGE SECTION

Helps relieve red, dry and irritated skin.

Helps clear away unpleasant reddish patches.

Helps restore the skin to its natural state.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

for any intended purpose other than indicated above.

When using this product

OTC - WHEN USING SECTION

do not swallow keep away from eyes

do not use other external care products

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

When using product for the first time, apply to a small area on the skin and wait for about 10 minutes. If there is no irritation, you may continue use.

For adults and children 6 months of age and over

For best results, apply the cream three times a day to clean skin.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, SUNFLOWER (HELIANTHUS ANNUUS) SEED OIL, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, GLYCERIN, SD ALCOHOL 40, DEHYDROACETIC ACID, BENZYL ALCOHOL, LACTIC ACID

SPL UNCLASSIFIED SECTION

The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the U.S. The letters ER indicate Eczema Relief.

Manufactured by:

Emilia Cosmetics LTD

Ha'mada 6, Yokneam

2069205, Israel

Made in Israel

Manufactured for:

ZBM Natural Medicine Ltd.

P.O. Box 2227

Industrial Zone

Kfar Saba 4464102

Israel

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopicSkin

Special Cream

HOMEOPATHIC CREAM FOR THE RELIEF OF SYMPTOMS OF ECZEMA: RASH, BURNING, ITCHING, CHAPPED, DRY, OR CRACKED SKIN: MENTHA PIPERITA L., MELISSA OFFICINALIS L., AND HYDRASTIS CANADENSIS L.

2.54fl oz (75ml)

Original Herbal Formula

Paraben Free

Fragrance Free

Colorant Free

Dermatologically Tested

To report a serious adverse event, contact

(210) 880-4960

Label1Label1

Label2Label2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69121-001-752020-01-31C16284748780-19d75b9d0-91de-f424-e053-dadaa90a57ceTopicSkin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69121-001-75TopicSkin75 mL in 1 TUBECREAM751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69121-001TOPICSKIN (HYDRASTIS CANADENSIS WHOLE, MENTHA PIPERITA, MELISSA OFFICINALIS) CREAM [ZBM NATURAL MEDICINE LTD.]1Legacy NDC, 1 package rows20141110_68e3dd5a-549d-4c70-9a00-83ac220aabea.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDRASTIS CANADENSIS WHOLEACTIVE INGREDIENTR763EBH88T1
MELISSA OFFICINALISACTIVE INGREDIENTYF70189L0N1
MENTHA PIPERITAACTIVE INGREDIENT79M2M2UDA91
HYDRASTIS CANADENSIS WHOLEACTIVE MOIETYR763EBH88T1
MELISSA OFFICINALISACTIVE MOIETYYF70189L0N1
MENTHA PIPERITAACTIVE MOIETY79M2M2UDA91
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE701
DEHYDROACETIC ACIDINACTIVE INGREDIENT2KAG279R6R1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5AT1
LAURETH-7INACTIVE INGREDIENTZ95S6G82011
POLYACRYLAMIDE (10000 MW)INACTIVE INGREDIENTE2KR9C9V2I1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69121-00169121-001-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDRASTIS CANADENSIS WHOLER763EBH88TACTIB
MENTHA PIPERITA79M2M2UDA9ACTIB
MELISSA OFFICINALISYF70189L0NACTIB
WATER059QF0KO0RIACT
SUNFLOWER OIL3W1JG795YIIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
GLYCERINPDC6A3C0OXIACT
DEHYDROACETIC ACID2KAG279R6RIACT
BENZYL ALCOHOLLKG8494WBHIACT
LACTIC ACID33X04XA5ATIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 145 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTERIAL0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATOINTMENT / TOPICALADJ PHExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATINJECTION / INTRAVENOUS2232 mgExact identifier — unii candidate
18 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAVENOUS45 mgExact identifier — unii candidate
50 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATINJECTION, SOLUTION / INTRAVENOUS87 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / ENDOTRACHEAL54 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTICULAR1 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATCAPSULE / ORAL132 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAMUSCULAR500 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATINJECTION / SUBCUTANEOUS10 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAMUSCULAR225 mgExact identifier — unii candidate
50 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATINJECTION / INTRACARDIAC0.01 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS144 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATTABLET / ORALADJ PHExact identifier — unii candidate
18 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / ORAL360 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATGEL / TOPICAL30 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSPRAY, METERED / NASAL5 mg/1mlExact identifier — unii candidate
50 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATINJECTION / INTRAMUSCULAR1.16 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRALESIONAL23 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAVENOUS400 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATSOLUTION / TOPICAL7.22 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRACAVITARY0.01 mlExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates

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
c2439eb0-35a1-4954-af4b-d0bdac16c76868e3dd5a-549d-4c70-9a00-83ac220aabea2014-11-10WarningsExact identifier
spl id: c2439eb0-35a1-4954-af4b-d0bdac16c768
spl set id: 68e3dd5a-549d-4c70-9a00-83ac220aabea

Reported adverse events (FAERS/openFDA)#

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