FDA.reportPublic FDA data

Insect Bite

Manufacturer
Deseret Biologicals, Inc. | Apotheca Company
Effective date
2024-09-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:27:55

Label at a glance#

ProductInsect Bite
Active ingredientHYPERICUM PERFORATUM WHOLE, LEDUM PALUSTRE TWIG, LATRODECTUS MACTANS, CITHARACANTHUS SPINICRUS, LYCOSA TARANTULA, LACHESIS MUTA VENOM, LYCOPUS VIRGINICUS, THERIDION CURASSAVICUM, CIMEX LECTULARIUS, FORMICA RUFA, PULEX IRRITANS, VESPA CRABRO, LOXOSCELES RECLUSA
Label structure9 sections

Dosage and administration

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Hypericum Perforatum 3X, Ledum Palustre 4X, Latrodectus Mactans 8X, 12X, 30X, 60X, 100X, Tarentula Cubensis 8X, 12X, 30X, 60X, 100X, Tarentula Hispana 8X, 12X, 30X, 60X, 100X, Lachesis Mutus 10X, Lycopus Virginicus 12X, Theridion 12X, 30X, 60X, 100X, Cimex Lectularius 15X, 30, Formica Rufa 15X, 30, Pulex Irritans 15X, 30, Vespa Crabro 15X, 30, Loxosceles Reclusa 12C, 30C, 100C.

HOMEOPATHIC INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of symptoms related to insect bites including swelling, fever, pain and rash.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

HOMEOPATHIC INDICAITONS:

INDICATIONS & USAGE SECTION

For temporary relief of symptoms related to insect bites including swelling, fever, pain and rash.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. By: Deseret Biologicals, Inc.
469 W. Parkland Drive
Sandy, UT 84070    www.desbio.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DESBIO

NDC 43742-0769-1

HOMEOPATHIC

INSECT BITE

1 FL OZ (30 ml)

Insect BiteInsect Bite

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43742-0769-1Insect Bite30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43742-0769INSECT BITE (HYPERICUM PERFORATUM, LEDUM PALUSTRE, LATRODECTUS MACTANS, TARENTULA CUBENSIS, TARENTULA HISPANA, LACHESIS MUTUS, LYCOPUS VIRGINICUS, THERIDION, CIMEX LECTULARIUS, FORMICA RUFA, PULEX IRRITANS, VESPA CRABRO, LOXOSCELES RECLUSA) LIQUID [DESERET BIOLOGICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20240913_10d86370-06fd-4cca-b53b-e9736edeab14.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43742-076943742-0769-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPERICUM PERFORATUM WHOLEXK4IUX8MNBACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
LATRODECTUS MACTANSXJJ7QA858RACTIB
CITHARACANTHUS SPINICRUS3Y5X6RT823ACTIB
LYCOSA TARANTULA86M454L2TTACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LYCOPUS VIRGINICUSTWH5125Q6FACTIB
THERIDION CURASSAVICUM9Z8D3HEM8LACTIB
CIMEX LECTULARIUSW66P4K3SGWACTIB
FORMICA RUFA55H0W83JO5ACTIB
PULEX IRRITANSL63DD62R8RACTIB
VESPA CRABROK3ALM8S49HACTIB
LOXOSCELES RECLUSA039G4OZ3G2ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
Insect BiteHYPERICUM PERFORATUM, LEDUM PALUSTRE, LATRODECTUS MACTANS, TARENTULA CUBENSIS, TARENTULA HISPANA, LACHESIS MUTUS, LYCOPUS VIRGINICUS, THERIDION, CIMEX LECTULARIUS, FORMICA RUFA, PULEX IRRITANS, VESPA CRABRO, LOXOSCELES RECLUSADeseret Biologicals, Inc.10d86370-06fd-4cca-b53b-e9736edeab142024-09-11WarningsExact identifier
ndc (package): 43742-0769-1
ndc (product): 43742-0769
ndc11 (package): 43742076901
spl id: 0cf259a0-eb33-412c-84c4-0d12cabc596f
spl set id: 10d86370-06fd-4cca-b53b-e9736edeab14

Reported adverse events (FAERS/openFDA)#

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