FDA.reportPublic FDA data

Diabetic First Aid Gel Professional

Manufacturer
Lavior Inc.
Effective date
2021-05-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:17

Label at a glance#

ProductDiabetic First Aid Gel Professional
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure13 sections

Indications and uses

First aid to help prevent infection in minor: ■cuts ■scrapes ■burns Temporarily relieves pain and itching associated with: ■minor burns ■cuts ■scrapes ■insect bites ■minor skin irritations

Dosage and administration

Adults and children 12 years of age and older: clean the affected area apply a small amount of this product on the area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first Children under 12 years of age: consult a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% .................Topical Antiseptic
Lidocaine Hydrochloride 0.5% .................Topical Analgesic

Purpose

OTC - PURPOSE SECTION

Topical Antiseptic
Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection in minor:

■cuts ■scrapes ■burns

Temporarily relieves pain and itching associated with:

■minor burns ■cuts ■scrapes ■insect bites ■minor skin irritations

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • over large areas of the body
  • in large quantities, particularly over raw surfaces or blistered areas

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition or symptoms get worse or last more than 1 week
  • symptoms clear up and occur again within a few days

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

Adults and children 12 years of age and older:

  • clean the affected area
  • apply a small amount of this product on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first


Children under 12 years of age: consult a doctor

Other information

OTC - WHEN USING SECTION

Store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Inula Viscosa Flower/Leaf/Stem Extract, Aloe Barbadensis Leaf Juice, Xanthan Gum, Phenoxyethanol, Allantoin, Tocopheryl Acetate, Ethylhexylglycerin, Gluconolactone, Polyvinyl Alcohol, Alcohol, Citric Acid, Sodium Benzoate, Potassium Sorbate

Questions?

OTC - QUESTIONS SECTION

Call toll free 1-844-474-2552 or visit www.lavior.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diabetic First Aid Gel ProDiabetic First Aid Gel Pro

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2535510benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical GelPSN1
2535510benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.005 MG/MG Topical GelSCD1
2535510benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71521-393-502023-01-30C16284748780-1f386c649-f243-0266-e053-dadaa90a7c1ac1ed633b-bbde-3ef2-e053-2a95a90a84b9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71521-393-50Diabetic First Aid Gel Professional50 g in 1 BOTTLE, PUMPGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71521-393DIABETIC FIRST AID GEL PROFESSIONAL (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) GEL [LAVIOR INC.]1Legacy NDC, 1 package rows20210510_c1ed633b-bbde-3ef2-e053-2a95a90a84b9.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71521-39371521-393-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALCOHOL3K9958V90MIACT
GLUCONOLACTONEWQ29KQ9POTIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BENZOATEOJ245FE5EUIACT
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
DITTRICHIA VISCOSA WHOLE3SYW69FH88IACT

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
c1ed16e6-7730-7f1e-e053-2a95a90adabcc1ed633b-bbde-3ef2-e053-2a95a90a84b92021-05-09WarningsExact identifier
spl id: c1ed16e6-7730-7f1e-e053-2a95a90adabc
spl set id: c1ed633b-bbde-3ef2-e053-2a95a90a84b9

Reported adverse events (FAERS/openFDA)#

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