FDA.reportPublic FDA data

finipil Lait 50

Manufacturer
Equibal, Inc.
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
18
Source
full-release
Hydrated at
2026-06-01 01:25:57

Label at a glance#

Productfinipil Lait 50
Active ingredientBENZETHONIUM CHLORIDE
Label structure11 sections

Dosage and administration

Directions Apply a small amount of this product on the area daily.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS

Active Ingredient

Benzethonium Chloride 0.2% w/w

Purpose

OTC - PURPOSE SECTION

Purpose

Antiseptic

Keep out of reach of children.

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 right away.

Use(s)

INDICATIONS & USAGE SECTION

Use(s)

  • first aid to help prevent bacterial contamination in minor cuts, scrapes and burns.
  • cools, soothes and moisturizes after hair removal.
  • recommended for repeated use.

Warnings Do not use in conjunction

WARNINGS SECTION

Warnings

For external use only

Do not use in conjunction

with products containing acids


Ask a doctor if

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a doctor ifpregnant or breast feeding,

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

irritation and redness develop

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

Apply a small amount of this product on the area daily.

When using this product

OTC - WHEN USING SECTION

When using this product do not get into eyes.

If contact occurs, rinse eyes thoroughly with water.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

Behentrimonium methosulfate, Bisabolol, Butylene Glycol, Cetyl Alcohol, Chlorhexidine Gluconate, Dimethicone, Matricaria (Chamomile Recutita) Extract, Menthyl Lactate, Octyldodecanol, Phenoxyethanol, Polyquarternium-37, Stearic Acid, Witch Hazel (Hamamelis Virginiana) Extract

finipil LAIT 50 Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

finipil®

soothes          antiseptic

moisturizes   cream

       protects

       against

       infection

       LAIT 50

        ●●●

Noncomedogenic

1.5 fl oz 44 ml

DRUG FACTS

Active Ingredient                                             Purpose

Benzethonium Chloride 0.2% w/w           Antiseptic

Uses(s)

  • first aid to help prevent bacterial contamination in minor cuts, scrapes, and burns.
  • cools, soothes, and moisturizes after hair removal.
  • recommended for repeated use.

Warnings

For external use only

Ask a doctor ifpregnant or breast feeding.

When using this product do not get into eyes.

if contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

irritation and redness develop

Do not use in conjunction

with products containing acids.

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply a small amount of this product on the area daily.

Inactive Ingredients

Behentrimonium Methosulfate, Bisabolol, Butylene Glycol, Cetyl Alcohol, Chlorhexidine Gluconate, Dimethicone, Matricaria (Chamomile Recutital) Extract, Menthyl Lactate, Octylodecanoil, Phenoxyethanol, Polyquaterniuim-37, Stearic Acid, Water, Witch Hazel (Hamamelis Virginiana) Extract

equibal labs

800-247-2405

nufree.com

Made in U.S.A.                                 

not tested on animals

patent# 8,603,550

Packaging 2.5ozPackaging 2.5ozPackaging 1.5ozPackaging 1.5oz

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53228-050-01finipil Lait 5044 mL in 1 TUBECREAM4418

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D057442
BENZETHONIUMACTIVE MOIETY1VU15B70BP2
BEHENTRIMONIUM METHOSULFATEINACTIVE INGREDIENT5SHP745C612
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN2
CHLORHEXIDINE GLUCONATEINACTIVE INGREDIENTMOR84MUD8E2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
HAMAMELIS VIRGINIANA TOPINACTIVE INGREDIENTUDA30A2JJY2
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T2
MATRICARIA RECUTITAINACTIVE INGREDIENTG0R4UBI2ZZ2
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7I2
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614Y2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYQUATERNIUM-37 (25000 MPA.S)INACTIVE INGREDIENT31L31U82852
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53228-05053228-050-01

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
BEHENTRIMONIUM METHOSULFATE5SHP745C61IACT
LEVOMENOL24WE03BX2TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CETYL ALCOHOL936JST6JCNIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
DIMETHICONE92RU3N3Y1OIACT
MATRICARIA RECUTITAG0R4UBI2ZZIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
OCTYLDODECANOL461N1O614YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYQUATERNIUM-37 (25000 MPA.S)31L31U8285IACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
HAMAMELIS VIRGINIANA TOPUDA30A2JJYIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
finipil Lait 50BENZETHONIUM CHLORIDEEquibal, Inc.bc630fbc-e428-4d46-8330-fb6f699943fd2025-12-16WarningsExact identifier
ndc (package): 53228-050-01
ndc (product): 53228-050
ndc11 (package): 53228005001
spl id: 461f32f5-973b-7cf2-e063-6294a90a254b
spl set id: bc630fbc-e428-4d46-8330-fb6f699943fd

Reported adverse events (FAERS/openFDA)#

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