FDA.reportPublic FDA data

Diabetic First Aid Gel - Lavior Pharma Inc.

Manufacturer
Lavior Pharma Inc.
Effective date
2026-03-26
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:51:45

Label at a glance#

ProductDiabetic First Aid Gel
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 gelDiabetic First Aid gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2535510benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical GelPSN10
2535510benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.005 MG/MG Topical GelSCD10
2535510benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical GelSY10

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeQR Codewww.lavior.comDB FIRST AID.jpg

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
71521-390-152026-01-29C16284748780-149896155-ba3c-586f-e063-e6dba90add90bda875e6-06bd-930f-e053-2995a90ab197
71521-390-302026-01-29C16284748780-149896155-ba3c-586f-e063-e6dba90add90bda875e6-06bd-930f-e053-2995a90ab197
71521-390-502026-01-29C16284748780-149896155-ba3c-586f-e063-e6dba90add90bda875e6-06bd-930f-e053-2995a90ab197

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71521-390-15Diabetic First Aid Gel15 g in 1 TUBEGEL1510
71521-390-30Diabetic First Aid Gel30 g in 1 TUBEGEL3010
71521-390-50Diabetic First Aid Gel50 g in 1 BOTTLE, PUMPGEL5010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71521-390-30ML - Milliliter71521-390b8ae663e-c92f-40b9-b96d-0924222d6a2112025-06-13

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
71521-39071521-390-50, 71521-390-15, 71521-390-30

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
Diabetic First Aid GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDELavior Pharma Inc.bda875e6-06bd-930f-e053-2995a90ab1972026-03-26WarningsExact identifier
ndc (package): 71521-390-30
ndc (package): 71521-390-15
ndc (package): 71521-390-50
ndc (product): 71521-390
ndc11 (package): 71521039015
ndc11 (package): 71521039050
ndc11 (package): 71521039030
spl id: 4df3c46f-fde3-1c53-e063-6294a90ab613
spl set id: bda875e6-06bd-930f-e053-2995a90ab197

Reported adverse events (FAERS/openFDA)#

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