FDA.reportPublic FDA data

UNDA 270 OINTMENT

Manufacturer
Seroyal USA | SAN’UP
Effective date
2020-09-23
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 02:13:19

Label at a glance#

ProductUNDA 270
Active ingredientHYPERICUM PERFORATUM, EQUISETUM ARVENSE TOP
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
This preparation contains:
Equisetum arvense (Common horsetail) Sterile Stem MT 0.1%
Hypericum perforatum (St. John's wort) Whole Plant MT 0.1%

OTC - PURPOSE SECTION

Uses
For the temporary relief of symptoms associated with

dry skin

itchy skin
other minor skin irritations

WARNINGS SECTION

Warnings
For external use only.
Stop use and ask a doctor if symptoms persist or worsen.
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a
Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

Cetostearyl alcohol, lanolin, lanolin alcohols, white petrolatum

OTHER SAFETY INFORMATION

Other information
Do not use if inner seal is missing or broken.

Store in a cool, dry place

DOSAGE & ADMINISTRATION SECTION

Directions
Adults: Apply a small amount on the affected area two to three times daily, or as recommended by your healthcare practitioner.

May cover affected area with sterile gauze after each application.

Children: Use under the direction of your healthcare practitioner.

INDICATIONS & USAGE SECTION

Uses
For the temporary relief of symptoms associated with

dry skin

itchy skin
other minor skin irritations

Directions
Adults: Apply a small amount on the affected area two to three times daily, or as recommended by your healthcare practitioner.

May cover affected area with sterile gauze after each application.

Children: Use under the direction of your healthcare practitioner.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62106-009762106-0097

NDC 62106-0097-0

UNDA topicals

UNDA 270 OINTMENT

Homeopathic Preparation

For the temporary relief of symptoms
associated with dry, itchy skin
and other minor skin irritations.

Net Weight 1.4 oz (40 g)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-0097-0UNDA 27040 g in 1 TUBECREAM4012
62106-0097-0UNDA 2701 in 1 CARTONCREAM112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-0097UNDA 270 (EQUISETUM ARVENSE, HYPERICUM PERFORATUM) CREAM [SEROYAL USA]12Current NDC, Legacy NDC, 2 package rows20200924_177bf6a0-69be-620a-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
EQUISETUM ARVENSE TOPACTIVE INGREDIENT1DP6Y6B65Z8
HYPERICUM PERFORATUMACTIVE INGREDIENTXK4IUX8MNB8
EQUISETUM ARVENSE TOPACTIVE MOIETY1DP6Y6B65Z8
HYPERICUM PERFORATUMACTIVE MOIETYXK4IUX8MNB8
LANOLININACTIVE INGREDIENT7EV65EAW6H8
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HE8

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62106-009762106-0097-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
EQUISETUM ARVENSE TOP1DP6Y6B65ZACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
LANOLIN7EV65EAW6HIACT

Source Document#

Source XML

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 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LANOLIN ALCOHOLSLANOLIN ALCOHOLS884C3FA9HECREAM / TOPICAL6 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LANOLIN ALCOHOLSLANOLIN ALCOHOLS884C3FA9HECREAM / TOPICAL6 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii+route+dosage form
2 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
UNDA 270EQUISETUM ARVENSE, HYPERICUM PERFORATUMSeroyal USA177bf6a0-69be-620a-e054-00144ff88e882020-09-23WarningsExact identifier
ndc (package): 62106-0097-0
ndc (product): 62106-0097
ndc11 (package): 62106009700
spl id: b00744c8-c5da-1933-e053-2a95a90ac67b
spl set id: 177bf6a0-69be-620a-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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