FDA.reportPublic FDA data

Itchy Bitten

Manufacturer
Kelada Creative Group
Effective date
2017-10-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:08:55

Label at a glance#

ProductItchy Bitten
Active ingredientPEPPERMINT OIL, CORYMBIA CITRIODORA LEAF OIL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Eucalyptus Oil .17%

Peppermint Oil.17%

OTC - PURPOSE SECTION

Temporarily relieves itching and discomfort associated with irritation, inflammation, and rashes due to insect bites, stings, poison ivy, oak and sumac

WARNINGS SECTION

For external use only

Do not use other than as directed

When using this product

  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or broken skin

INDICATIONS & USAGE SECTION

Temporarily relieves itching and discomfort associated with irritation, inflammation, and rashes due to insect bites, stings, poison ivy, oak and sumac​

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

INACTIVE INGREDIENT SECTION

Organic Extra Virgin Olive Oil, Sweet Almond Oil, Organic Wild Harvested Chickweed Oil, Beeswax, Organic Marigold Oil, French Lavender Essential Oil, Spanish Rosemary Essential Oil, Natural Vitamin E.

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 3 years of age and older; lightly apply to affected area not more than 5 times daily
  • Children under 3 years of age; ask a doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ItchyItchy

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71157-0018-12020-01-31C16284748780-19d75b9d0-08ce-f424-e053-dadaa90a57ceItchy/Bitten

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71157-0018-1Itchy Bitten90 mL in 1 CANGEL903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71157-0018ITCHY BITTEN (EUCALYPTUS PEPPERMINT OIL) GEL [KELADA CREATIVE GROUP]3Legacy NDC, 1 package rows20171016_451e52eb-8588-6127-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71157-001871157-0018-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
STELLARIA MEDIA LEAFE6M924345XIACT
WHITE WAX7G1J5DA97FIACT
LAVENDER OILZBP1YXW0H8IACT
ROSEMARY OIL8LGU7VM393IACT
PEPPERMINT OILAV092KU4JHACTIB
OLIVE OIL6UYK2W1W1EIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
CORYMBIA CITRIODORA LEAF OILM63U6N96EBACTIB
ALMOND OIL66YXD4DKO9IACT

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
5ba9ea67-9ea7-f0b7-e053-2991aa0a634b451e52eb-8588-6127-e054-00144ff8d46c2017-10-16WarningsExact identifier
spl id: 5ba9ea67-9ea7-f0b7-e053-2991aa0a634b
spl set id: 451e52eb-8588-6127-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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