FDA.reportPublic FDA data

Fast Freeze Lidocaine

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 00:22:40

Label at a glance#

ProductFast Freeze Lidocaine
Active ingredientLIDOCAINE
Label structure7 sections

Indications and uses

Temporary relief of minor pain

Dosage and administration

Shake well Adults and children over 12 years: Apply a thin layer to affected area not more than 3 to 4 times daily To apply to face, spray into palm of hand and gently apply Children under 12 years of age, ask a doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

PURPOSE

OTC - PURPOSE SECTION

Topical Anesthetic

USES

INDICATIONS & USAGE SECTION

Temporary relief of minor pain

WARNINGS

WARNINGS SECTION

For external use only

DO NOT USE

OTC - DO NOT USE SECTION

  • In large quantities, particularly over raw surfaces or blistered areas

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • Keep out of eyes
  • Use only as directed
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms persist for more than 7 days or 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 PETSIf swallowed, get medical help or contact a Poison Control Center right away

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Shake well

  • Adults and children over 12 years:

Apply a thin layer to affected area not more than 3 to 4 times daily

  • To apply to face, spray into palm of hand and gently apply
  • Children under 12 years of age, ask a doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Deionized Water, Diazolidinyl Urea. Dimethicone, Disodium Cocamphodipropionate. Disodium EDTA, Glycerin. Propylene Glycol, SDA 39C Alcohol, Tocopheryl Acetate, Triethanolamine.

Principal Display Panel – 118 mL Can Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAST FREEZE®

MAXIMUM STRENGTH
LIDOCAINE
CONTINUOUS SPRAY

UNSCENTED

  • Numbing relief
  • No mess, greaseless & stain-free
  • Natural ingredients include
    Vitamin E and Aloe
  • For the temporary relief of
    minor aches and pains of muscles
    and joints; associated with backache,
    arthritis, strains and sprains
  • Paraben Free
  • Fast Drying

3 oz (89 mL)

Principal Display Panel – 118 mL Can Label
Principal Display Panel – 118 mL Can Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1869797lidocaine 4 % Topical SprayPSN2
1869797lidocaine 40 MG/ML Topical SpraySCD2
1869797lidocaine 4 % Topical SpraySY2

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
66902-225-04Fast Freeze Lidocaine118 mL in 1 CANSPRAY1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66902-225FAST FREEZE LIDOCAINE (LIDOCAINE) SPRAY [NATURAL ESSENTIALS, INC.]2Current NDC, Legacy NDC, 1 package rows20241006_029bd3fb-1b5b-48e0-b9af-d91d548b5b0f.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66902-22566902-225-04

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
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
ALOE VERA LEAFZY81Z83H0XIACT
MATRICARIA CHAMOMILLA FLOWERING TOP3VNC7T6Z02IACT
CUCUMBERYY7C30VXJTIACT
WATER059QF0KO0RIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
DIMETHICONE92RU3N3Y1OIACT
DISODIUM COCOAMPHODIPROPIONATE6K8PRP397MIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALCOHOL3K9958V90MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE98PI200987ACTIB

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 LidocaineLIDOCAINENatural Essentials, Inc.029bd3fb-1b5b-48e0-b9af-d91d548b5b0f2024-10-04WarningsExact identifier
ndc (package): 66902-225-04
ndc (product): 66902-225
ndc11 (package): 66902022504
spl id: 23a8b37e-ce10-477b-e063-6394a90a337d
spl set id: 029bd3fb-1b5b-48e0-b9af-d91d548b5b0f

Reported adverse events (FAERS/openFDA)#

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