FDA.reportPublic FDA data

Fast Freeze Lidocaine Roll-On

Manufacturer
Natural Essentials, Inc.
Effective date
2024-10-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:44

Label at a glance#

ProductFast Freeze Lidocaine Roll-On
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL
Label structure9 sections

Indications and uses

Temporary relief of minor pain

Dosage and administration

Adults and children 12 years of age and over clean and dry affected area apply to affected area not more than 3 to 4 times daily children 12 years or younger ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Benzyl Alcohol 10%

PURPOSE

OTC - PURPOSE SECTION

Topical Anesthetic

Topical Anesthetic

USES

INDICATIONS & USAGE SECTION

Temporary relief of minor pain

WARNINGS

WARNINGS SECTION

For external use only

FLAMMABLE:Keep away from fire or flame

DO NOT USE

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • in large quantities
  • with a heating pad
  • if you are allergic to any ingredients of this product

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

  • skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN AND PETS.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 over
  • clean and dry affected area
  • apply to affected area not more than 3 to 4 times daily children 12 years or younger ask a doctor

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store with lid closed tightly

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Citric Acid, Deionized Water, SDA 40-B Alcohol, Tromethamine

Principal Display Panel – 89 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAST FREEZE ®

MAXIMUM STRENGTH
LIDOCAINE
ROLL-ON

UNSCENTED

  • Numbing relief
  • No mess, greaseless & stain-free
  • Natural ingredients include Aloe
  • For the temporary relief of
    minor aches and pains of muscles
    and joints; associated with backache,
    arthritis, strains and sprains
  • Paraben Free
  • Plus 10% Benzyl Alcohol

3 oz (89 mL)

Principal Display Panel – 89 mL Container Label
Principal Display Panel – 89 mL Container Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1943537benzyl alcohol 10 % / lidocaine HCl 4 % Topical SolutionPSN2
1943537benzyl alcohol 0.1 ML/ML / lidocaine hydrochloride 40 MG/ML Topical SolutionSCD2
1943537benzyl alcohol 10 % / lidocaine HCl 4 % Topical SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZYL ALCOHOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66902-235-03Fast Freeze Lidocaine Roll-On89 mL in 1 CONTAINERLIQUID892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66902-235FAST FREEZE LIDOCAINE ROLL-ON (LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL) LIQUID [NATURAL ESSENTIALS, INC.]2Current NDC, Legacy NDC, 1 package rows20241006_74b06366-5eb4-4eba-aa2b-2b672828294d.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66902-23566902-235-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZYL ALCOHOLLKG8494WBHACTIB

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
Fast Freeze Lidocaine Roll-OnLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNatural Essentials, Inc.74b06366-5eb4-4eba-aa2b-2b672828294d2024-10-04WarningsExact identifier
ndc (package): 66902-235-03
ndc (product): 66902-235
ndc11 (package): 66902023503
spl id: 23a8a69d-a66a-47bd-e063-6394a90af015
spl set id: 74b06366-5eb4-4eba-aa2b-2b672828294d

Reported adverse events (FAERS/openFDA)#

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