FDA.reportPublic FDA data

Itch Relief

Manufacturer
Similasan AG
Effective date
2021-04-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:14:33

Label at a glance#

ProductItch Relief
Active ingredientAPIS MELLIFERA, LACHESIS MUTA VENOM, LEDUM PALUSTRE TWIG, URTICA URENS
Label structure18 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms associated with insect bites & stings and minor skin irritations due to poison ivy, oak & sumac such as: pain itching

Dosage and administration

For adults and children age 2 and over: Moisten the affected area with roller ball at short intervals several times a day until the symptoms clearly diminish. Continue to apply 3-6 times daily until the affected area is completely cleared up.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Apis mellifica 12X

Purpose

OTC - PURPOSE SECTION

stinging, pain, redness, burning

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lachesis mutus 12X

Purpose

OTC - PURPOSE SECTION

burning, skin discoloration

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ledum palustre 6X

Purpose

OTC - PURPOSE SECTION

itching, skin irritation

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Urtica urens 8X

Purpose

OTC - PURPOSE SECTION

itching, burning, skin irritation and rashes

Uses:

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms associated with insect bites & stings and minor skin irritations due to poison ivy, oak & sumac such as: pain itching

Warnings:

WARNINGS SECTION

  • For external use only.
  • According to homeopathic principles, symptoms may temporarily worsen before improving (initial exacerbation of symptoms).
  • Avoid contact with the eyes.
  • If conditions worsen or persist for more than 72 hours discontinue use and consult a physician.

If pregnant, trying to get 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

For adults and children age 2 and over: Moisten the affected area with roller ball at short intervals several times a day until the symptoms clearly diminish. Continue to apply 3-6 times daily until the affected area is completely cleared up.

Other Information:

OTHER SAFETY INFORMATION

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Alcohol, 40% V/V, Vegetable glycerin

Questions?

OTC - QUESTIONS SECTION

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.

www.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Similasan®
Itch Relief  
ROLL-ON
7.5 mL/0.25 fl oz

PRINCIPAL DISPLAY PANEL Similasan® Itch Relief ROLL-ON 7.5 mL/0.25 fl ozPRINCIPAL DISPLAY PANEL Similasan® Itch Relief ROLL-ON 7.5 mL/0.25 fl oz

PRINCIPAL DISPLAY PANEL Similasan® Itch Relief ROLL-ON 7.5 mL/0.25 fl ozPRINCIPAL DISPLAY PANEL Similasan® Itch Relief ROLL-ON 7.5 mL/0.25 fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-220-422023-01-30C16284748780-1f386c64a-0469-0266-e053-dadaa90a7c1aItch Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-220-42Itch Relief7.5 mL in 1 BOTTLE, WITH APPLICATORLIQUID7.52
53799-220-42Itch Relief1 in 1 BOXLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-220ITCH RELIEF (APIS MELLIFERA, LACHESIS MUTA VENOM, LEDUM PALUSTRE TWIG AND URTICA URENS) LIQUID [SIMILASAN AG]2Legacy NDC, 2 package rows20210424_9c0ab676-c8a4-4896-b91d-720d280a135d.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53799-22053799-220-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
APIS MELLIFERA7S82P3R43ZACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
URTICA URENSIHN2NQ5OF9ACTIB
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT

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
d4452115-6c33-4fc5-a362-f0f64ee8f13f9c0ab676-c8a4-4896-b91d-720d280a135d2021-04-26WarningsExact identifier
spl id: d4452115-6c33-4fc5-a362-f0f64ee8f13f
spl set id: 9c0ab676-c8a4-4896-b91d-720d280a135d

Reported adverse events (FAERS/openFDA)#

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