FDA.reportPublic FDA data

Lanacane ® Maximum Strength Anti-Itch Cream

Manufacturer
RB Health (US) LLC
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:19:46

Label at a glance#

ProductLanacane Maximum Strength Anti-Itch
Active ingredientBENZETHONIUM CHLORIDE, BENZOCAINE
Label structure10 sections

Indications and uses

first aid for the temporary relief of pain and itching and to help prevent infection in minor cuts, scrapes and burns

Dosage and administration

adults and children 2 years of age and older: clean the affected area and apply a small amount to the affected area not more than 1 to 3 times daily children under 2 years of age: ask a doctor may be covered with a sterile bandage

Storage and handling

store at 20-25°C (68-77°F) retain carton for future reference

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Benzethonium chloride 0.2%First-aid antiseptic
Benzocaine 20%Pain relief cream

Uses

INDICATIONS & USAGE SECTION

first aid for the temporary relief of pain and itching and to help prevent infection in minor cuts, scrapes and burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • over large areas of the body

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 worsens
  • needed for longer than 1 week

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: clean the affected area and apply a small amount to the affected area not more than 1 to 3 times daily
  • children under 2 years of age: ask a doctor
  • may be covered with a sterile bandage

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • retain carton for future reference

Inactive ingredients

INACTIVE INGREDIENT SECTION

acetylated lanolin alcohol, aloe, cetyl acetate, cetyl alcohol, cholecalciferol, corn oil, dimethicone, dl-alpha tocopherol acetate, fragrance, glycerin, glyceryl monostearate, isopropyl myristate, methylparaben, mineral oil, PEG-100 stearate, polyvinylpyrrolidone/eicosene copolymer, propylparaben, pyrithione zinc, retinyl palmitate, sorbitan monostearate, stearamidopropyl PG-dimonium chloride phosphate, water

Questions?

OTC - QUESTIONS SECTION

1-866-252-5327.

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Distributed by: RB Health (US)
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-810-01

LANACANE ®

Maximum Strength

ANTI-ITCH
CREAM

Benzethonium chloride 0.2%
(First-Aid Antiseptic)
Benzocaine 20%
(Pain Relieving Cream)

2-in-1

FAST Acting
Itch Relief

+

Kills Germs*
*unlike Hydrocortisones

Temporary itch relief from:

  • Insect bites
  • Rashes
  • Dry, Itchy skin

NET WT. 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-810LANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RB HEALTH (US) LLC]7Legacy NDC20231130_96eb2dcc-4653-452a-9abd-fe92114a14ad.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-810-01GM - Gram63824-8107f7b3b8d-0ca6-47a5-858a-633d50b0f01212014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzethonium chlorideACTIVE INGREDIENTPH41D057443
BenzocaineACTIVE INGREDIENTU3RSY48JW53
BenzethoniumACTIVE MOIETY1VU15B70BP3
BenzocaineACTIVE MOIETYU3RSY48JW53
.alpha.-tocopherol acetate, dl-INACTIVE INGREDIENTWR1WPI7EW83
acetylated lanolin alcoholsINACTIVE INGREDIENTSNN716810P3
aloeINACTIVE INGREDIENTV5VD430YW93
cetyl acetateINACTIVE INGREDIENT4Q43814HXS3
cetyl alcoholINACTIVE INGREDIENT936JST6JCN3
cholecalciferolINACTIVE INGREDIENT1C6V77QF413
corn oilINACTIVE INGREDIENT8470G57WFM3
dimethiconeINACTIVE INGREDIENT92RU3N3Y1O3
glycerinINACTIVE INGREDIENTPDC6A3C0OX3
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE43
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJS3
methylparabenINACTIVE INGREDIENTA2I8C7HI9T3
mineral oilINACTIVE INGREDIENTT5L8T28FGP3
PEG-100 stearateINACTIVE INGREDIENTYD01N1999R3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH3
pyrithione zincINACTIVE INGREDIENTR953O2RHZ53
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58X3
stearamidopropyl PG-dimonium chloride phosphateINACTIVE INGREDIENTW6000VEI5Y3
vitamin A palmitateINACTIVE INGREDIENT1D1K0N0VVC3
waterINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-81063824-810-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETYLATED LANOLIN ALCOHOLSSNN716810PIACT
ALOEV5VD430YW9IACT
CETYL ACETATE4Q43814HXSIACT
CETYL ALCOHOL936JST6JCNIACT
CHOLECALCIFEROL1C6V77QF41IACT
CORN OIL8470G57WFMIACT
DIMETHICONE92RU3N3Y1OIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PEG-100 STEARATEYD01N1999RIACT
PROPYLPARABENZ8IX2SC1OHIACT
PYRITHIONE ZINCR953O2RHZ5IACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
STEARAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATEW6000VEI5YIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
WATER059QF0KO0RIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB
BENZOCAINEU3RSY48JW5ACTIB

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 6 · 338 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
glycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PERIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAMUSCULAR6 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHDROPS / NASAL14 mgExact identifier — unii candidate
68 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TJELLY / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRAMUSCULAR95 mgExact identifier — unii candidate
79 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, EXTENDED RELEASE / ORAL132 mgExact identifier — unii candidate
20 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHFILM / BUCCAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHDROPS / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
isopropyl myristateISOPROPYL MYRISTATE0RE8K4LNJSSYSTEM / TRANSDERMAL113 mgExact identifier — unii candidate
18 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSPRAY / TOPICAL0.8 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SUBCUTANEOUS22 mgExact identifier — unii candidate
79 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, ORALLY DISINTEGRATING / ORAL9 mgExact identifier — unii candidate
20 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSPRAY / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4OINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TDROPS / AURICULAR (OTIC)0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHJELLY / TOPICAL180 mgExact identifier — unii candidate
68 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
21 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHPOWDER / ORALNAExact identifier — unii candidate
68 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii candidate
21 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET / SUBLINGUAL1.23 mgExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / EPIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM / VAGINAL3 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XSPRAY / TOPICAL4.58 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TDROPS / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSYSTEM / TOPICAL42 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii candidate
79 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSHAMPOO / TOPICAL0.03 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 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
0b531eba-2bb5-8bae-e063-6294a90a8dca96eb2dcc-4653-452a-9abd-fe92114a14ad2023-11-29WarningsExact identifier
spl id: 0b531eba-2bb5-8bae-e063-6294a90a8dca
spl set id: 96eb2dcc-4653-452a-9abd-fe92114a14ad

Reported adverse events (FAERS/openFDA)#

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