Lansinoh Anti-itch

Manufacturer
Lansinoh Laboratories Inc | Dhaliwal Pharmaceuticals Laboratories, LLC
Effective date
2024-12-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:13

Label at a glance#

ProductLansinoh Anti-itch
Active ingredientMENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsPurpose
Menthol 0.5%Topical Analgesic

OTC - ASK DOCTOR SECTION

Stop Use and ask a doctor

  • if condition worsens
  • if symptoms persist for more than 7 days
  • Or if symptoms clear up and occur again withina few days

OTC - DO NOT USE SECTION

Do NOT use in or near mouth, or on breasts or nipples when breast feeding.

Pregnant women are advised to consult their physician before using any OTC drug product.

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 awau (1-800-222-1222)

OTC - PURPOSE SECTION

For temporary relief of itching

OTC - STOP USE SECTION

Stop use and ask a doctor

  • If condition worsens
  • If symptoms persists for more than 7 days
  • Or if symptoms clear up and occur again within a few days

WARNINGS SECTION

Warnings

For external use only

Avoid contact withthe eyes

DOSAGE & ADMINISTRATION SECTION

Directions

  • For adults and children 2 years and older
  • Apply externally to the affected area, no more than 3-4 times daily

INACTIVE INGREDIENT SECTION

Inactive Ingredients:
Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Meal Extract, Caprylyl Glycol, Carbomer, Cetearyl Olivate, Cucumis Sativus Fruit Extract, Cyclopentasiloxane, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Glycerin, Hyaluronic Acid, Hydrolyzed Jojoba Esters, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isopropyl Palmitate, Polysorbate 60, Prunus Armeniaca (Apricot) Kernel Oil), Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Benzoate, Potassium Sorbate, Sodium Chloride, Sodium Hydroxide, Sorbitan Isostearate, 1,2-Hexanediol, Sorbitan Olivate, Squalane, Water (Eau, Aqua).

INDICATIONS & USAGE SECTION

Uses
For temporary relief of itching

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug fact and frontDrug fact and front

frontfront

Display cartoonDisplay cartoon

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1114454menthol 0.5 % Topical CreamPSN2
1114454menthol 5 MG/ML Topical CreamSCD2
1114454menthol 0.5 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53997-002-01Lansinoh Anti-itch125 mL in 1 TUBECREAM1252
53997-002-02Lansinoh Anti-itch1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53997-002LANSINOH ANTI-ITCH (MENTHOL 0.5%) CREAM [LANSINOH LABORATORIES INC]22 package rows20241224_19357c7f-b7fa-dacc-e063-6394a90ad1c1.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53997-00253997-002-01, 53997-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

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
29e5abb1-50cf-6438-e063-6294a90a1ae619357c7f-b7fa-dacc-e063-6394a90ad1c12024-12-22WarningsExact identifier
spl id: 29e5abb1-50cf-6438-e063-6294a90a1ae6
spl set id: 19357c7f-b7fa-dacc-e063-6394a90ad1c1

Reported adverse events (FAERS/openFDA)#

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