FDA.reportPublic FDA data

ZymaDerm for Cold Sores

Manufacturer
Naturopathix, Inc.
Effective date
2021-01-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:14:07

Label at a glance#

ProductZymaDerm for Cold Sores
Active ingredientIODINE, CINNAMOMUM CAMPHORA WHOLE, MELISSA OFFICINALIS, BETA VULGARIS, BASIL, MENTHA PIPERITA
Label structure18 sections

Indications and uses

Helpful as an aid in the relief of skin symptoms caused by cold sores.

Dosage and administration

Apply to blisters and sores every 2 hours or at least 4 times a day. Begin application at the earliest sign of prodromal symptoms such as itching, tingling, burning, or pain. Minimize contact with normal skin.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

5x Iodum    

Purpose

OTC - PURPOSE SECTION

Topical anti-viral

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

5x Cinnamomum camphora

Purpose

OTC - PURPOSE SECTION

Anti-inflammatory

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

3x Melissa officinalis

Purpose

OTC - PURPOSE SECTION

Topical anti-viral

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

4x Ammonica quatranarium

Purpose

OTC - PURPOSE SECTION

Topical anti-viral

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

5x Ocimum basilicum

Purpose

OTC - PURPOSE SECTION

Immune stimulant

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

3x Mentha piperata

Purpose

OTC - PURPOSE SECTION

Topical anti-viral

Uses:

INDICATIONS & USAGE SECTION

Helpful as an aid in the relief of skin symptoms caused by cold sores.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply to blisters and sores every 2 hours or at least 4 times a day. Begin application at the earliest sign of prodromal symptoms such as itching, tingling, burning, or pain. Minimize contact with normal skin.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

NOT TO BE TAKEN INTERNALLY. CONTAINS IODINE.

Discontinue if redness of surrounding skin develops, or if pain or discomfort develop. If there is any development you are unsure about, stop ZymaDerm™ and call 1-800-694-6855 to discuss your concerns. IF YOU ARE ALLERGIC TO IODINE CONSULT YOUR PHYSICIAN PRIOR TO USE. If swallowed, give water. Flush with water if accidental contact with eyes occurs. Spills may be cleaned with rubbing alcohol.

Other Ingredients:

INACTIVE INGREDIENT SECTION

M. alternifolia, Jojoba oil, high selenium canola oil

Distributed by Naturopathix, Inc. Boise, ID 1-800-694-6855
Net Contents ½ fl. oz.
©2003 Naturopathix, Inc. Boise, ID  All rights reserved.      Homeopathic
US Patent # 7,311,928

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZymaDermTM 
for Cold Sores

Principal Display Panel ZymaDerm for Cold SoresPrincipal Display Panel ZymaDerm for Cold Sores

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69163-4132-22023-01-30C16284748780-1f386c649-ca63-0266-e053-dadaa90a7c1aZymaDerm for Cold Sores

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69163-4132-2ZymaDerm for Cold Sores1 in 1 BOXLIQUID13
69163-4132-2ZymaDerm for Cold Sores13 mL in 1 BOTTLE, GLASSLIQUID133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69163-4132ZYMADERM FOR COLD SORES (IODINE, CINNAMOMUM CAMPHORA WHOLE, MELISSA OFFICINALIS, BETA VULGARIS, BASIL AND MENTHA PIPERITA) LIQUID [NATUROPATHIX, INC.]3Legacy NDC, 2 package rows20210113_8fd686db-af67-441e-be6f-f4983c713ece.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BASILACTIVE INGREDIENT2U0KZP0FDW1
BETA VULGARISACTIVE INGREDIENT4G174V50511
CINNAMOMUM CAMPHORA WHOLEACTIVE INGREDIENT0B27814T7X1
IODINEACTIVE INGREDIENT9679TC07X41
MELISSA OFFICINALISACTIVE INGREDIENTYF70189L0N1
MENTHA PIPERITAACTIVE INGREDIENT79M2M2UDA91
BASILACTIVE MOIETY2U0KZP0FDW1
BETA VULGARISACTIVE MOIETY4G174V50511
CINNAMOMUM CAMPHORA WHOLEACTIVE MOIETY0B27814T7X1
IODINEACTIVE MOIETY9679TC07X41
MELISSA OFFICINALISACTIVE MOIETYYF70189L0N1
MENTHA PIPERITAACTIVE MOIETY79M2M2UDA91
CANOLA OILINACTIVE INGREDIENT331KBJ17RK1
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69163-413269163-4132-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
IODINE9679TC07X4ACTIB
CINNAMOMUM CAMPHORA WHOLE0B27814T7XACTIB
MELISSA OFFICINALISYF70189L0NACTIB
BETA VULGARIS4G174V5051ACTIB
BASIL2U0KZP0FDWACTIB
MENTHA PIPERITA79M2M2UDA9ACTIB
TEA TREE OILVIF565UC2GIACT
JOJOBA OIL724GKU717MIACT
CANOLA OIL331KBJ17RKIACT

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
0eec5a80-2125-48fd-9df6-6f1a0e9da33f8fd686db-af67-441e-be6f-f4983c713ece2021-01-15WarningsExact identifier
spl id: 0eec5a80-2125-48fd-9df6-6f1a0e9da33f
spl set id: 8fd686db-af67-441e-be6f-f4983c713ece

Reported adverse events (FAERS/openFDA)#

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