FDA.reportPublic FDA data

Simplicity Desensitizing Gel

Manufacturer
Simplicity Laser, LLC | Results RNA, LLC
Effective date
2014-07-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:39:44

Label at a glance#

ProductSimplicity Desensitizing
Active ingredientLIDOCAINE
Label structure8 sections

Dosage and administration

Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily. Children under 2 years of age: Consult a doctor.

Storage and handling

Store at USP controlled room temperature 20-25 deg.C (68-77 deg.F).

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% w/w

Purpose

OTC - PURPOSE SECTION


Topical anesthetic

Use:

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to:

  • minor cuts
  • minor scrapes
  • sunburn
  • minor skin irritations
  • minor burns
  • insect bites

Warnings:

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask doctor if

OTC - ASK DOCTOR SECTION

  • Allergic reaction occurs
  • Condition worsens or does not improve within 7 days
  • Symptoms clear up and return within a few days
  • Redness, irritation, swelling, pain or other symptoms begin or increase

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 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years of age: Consult a doctor.

Other Information

STORAGE AND HANDLING SECTION

Store at USP controlled room temperature 20-25 deg.C (68-77 deg.F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ag,carbomer 940, deionized water

Simplicity Desensitizing Gel, 1 fl oz/30mL (69109-004-30)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label1Label1

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1291672lidocaine 4 % Topical GelPSN4
1291672lidocaine 0.04 MG/MG Topical GelSCD4
1291672lidocaine 4 % Topical GelSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69109-004-302019-11-27C16284748780-19855e2a2-4056-60a7-e053-dbdaa90a05bdSimplicity Desensitizing Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69109-004-30Simplicity Desensitizing30 mL in 1 BOTTLEGEL304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69109-004SIMPLICITY DESENSITIZING (LIDOCAINE) GEL [ SIMPLICITY LASER, LLC]4Legacy NDC, 1 package rows20140715_8660021c-69c4-49c3-959d-2182c581aa0f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI2009874
LIDOCAINEACTIVE MOIETY98PI2009874
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69109-00469109-004-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
WATER059QF0KO0RIACT

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 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL, METERED / TRANSDERMAL50 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EOINTMENT, AUGMENTED / TOPICAL23 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ELOTION / TOPICAL300 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TRANSDERMAL150 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / OPHTHALMIC4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EEMULSION / TOPICAL6 mgExact identifier — unii candidate
9 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
fc59ad0a-e1a6-40e9-a273-07086413c6168660021c-69c4-49c3-959d-2182c581aa0f2014-07-15WarningsExact identifier
spl id: fc59ad0a-e1a6-40e9-a273-07086413c616
spl set id: 8660021c-69c4-49c3-959d-2182c581aa0f

Reported adverse events (FAERS/openFDA)#

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