FDA.reportPublic FDA data

BLACK FLY GUARD

Manufacturer
RESOLUTIONS LLC
Effective date
2021-12-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:15:14

Label at a glance#

ProductBLACK FLY GUARD
Active ingredientAZADIRACHTA INDICA SEED OIL
Label structure8 sections

Indications and uses

PREVENTS BLACK FLY BITES ALL NATURAL PLANT OILS LONG LASTING PROTECTION

Dosage and administration

(FOR CHILDREN 2 YEARS AND OLDER AND ADULTS): APPLY SUNSCREEN FIRST, ESPECIALLY SPRAY-ON SUNSCREENS WHICH CONTAIN ALCOHOL (ALCOHOL REMOVES OUR PRODUCT). IF A SPRAY-ON SUNSCREEN IS REAPPLIED, THEN OUR PRODUCT MUST BE REAPPLIED TOO.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

NEEM OIL 3%

PURPOSE

OTC - PURPOSE SECTION

BLACK FLY GUARD

USES

INDICATIONS & USAGE SECTION

  • PREVENTS BLACK FLY BITES
  • ALL NATURAL PLANT OILS
  • LONG LASTING PROTECTION

WARNINGS SECTION

TOPICAL OIL - FOR EXTERNAL USE ONLY - KEEP OUT OF EYES. FLUSH THOROUGHLY AND GENTLY WITH WARM WATER FOR 10-15 MINUTES. STOP USE AND CONSULT PHYSICIAN IF RASH OR IRRITATION DEVELOPS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN: IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

(FOR CHILDREN 2 YEARS AND OLDER AND ADULTS):

APPLY SUNSCREEN FIRST, ESPECIALLY SPRAY-ON SUNSCREENS WHICH CONTAIN ALCOHOL (ALCOHOL REMOVES OUR PRODUCT). IF A SPRAY-ON SUNSCREEN IS REAPPLIED, THEN OUR PRODUCT MUST BE REAPPLIED TOO.

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

FRACTIONATED COCONUT OIL, OLIVE OIL, AVOCADO OIL, HIGH OLEIC SAFFLOWER OIL, CINNAMOM OIL, D-ALPHA TOCOPHEROL (VITAMIN E).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_105172.Black_Fly_guard_label01b LBL_105172.Black_Fly_guard_label

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
63264-201-142023-01-30C16284748780-1f386c649-b62b-0266-e053-dadaa90a7c1aRESOLUTIONS - BLACK FLAG GUARD (63264-201)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63264-201-14BLACK FLY GUARD118 mL in 1 BOTTLEOIL1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63264-201BLACK FLY GUARD (NEEM) OIL [RESOLUTIONS LLC]1Legacy NDC, 1 package rows20211218_d3601d8d-bf02-7f6f-e053-2a95a90ab166.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63264-20163264-201-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
AZADIRACHTA INDICA SEED OIL4DKJ9B3K2TACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
OLIVE OIL6UYK2W1W1EIACT
AVOCADO OIL6VNO72PFC1IACT
SAFFLOWER OIL65UEH262ISIACT
TOCOPHEROLR0ZB2556P8IACT
CINNAMON OILE5GY4I6YCZIACT

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
d3601d8d-bf03-7f6f-e053-2a95a90ab166d3601d8d-bf02-7f6f-e053-2a95a90ab1662021-12-17WarningsExact identifier
spl id: d3601d8d-bf03-7f6f-e053-2a95a90ab166
spl set id: d3601d8d-bf02-7f6f-e053-2a95a90ab166

Reported adverse events (FAERS/openFDA)#

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