FDA.reportPublic FDA data

Fruit of the Earth Cool Blue Aloe Mist Continuous Spray

Manufacturer
Fruit Of The Earth, Inc.
Effective date
2024-10-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:27:33

Label at a glance#

ProductFruit of the Earth Cool Blue Aloe Mist Continuous
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

For the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations.

Dosage and administration

Adults and children 2 years of age and older; spray onto affected area not more than 3 to 4 times daily. Hold container 4 to 6 inches away from face from affected area to apply Children under 2 years of age: ask a doctor. To apply to the face, spray into hand and apply.

Storage and handling

May stain some fabrics.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 1% (as Lidocaine HCl)

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations.

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

  • Avoid sprying in eyes. Rinse with water to remove.
  • Do not puncture or incinerate. Contents under pressure.
  • do not store at temperatures above 120°F.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • condition worsens
  • symptoms persist more than 7 days
  • symptoms clear up and occur again within a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older; spray onto affected area not more than 3 to 4 times daily. Hold container 4 to 6 inches away from face from affected area to apply
  • Children under 2 years of age: ask a doctor.
  • To apply to the face, spray into hand and apply.

Other information

STORAGE AND HANDLING SECTION

May stain some fabrics.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Isoceteth-20, Triethanolamine, Carbomer, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4, Blue 1.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61332D361332D3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62217-095-25Fruit of the Earth Cool Blue Aloe Mist Continuous177 g in 1 CANISTERSPRAY1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62217-095FRUIT OF THE EARTH COOL BLUE ALOE MIST CONTINUOUS (LIDOCAINE HYDROCHLORIDE) SPRAY [FRUIT OF THE EARTH, INC.]2Current NDC, Legacy NDC, 1 package rows20241020_d4caae4c-efba-2453-e053-2995a90a5e5f.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62217-09562217-095-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ISOCETETH-20O020065R7ZIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
EDETATE SODIUMMP1J8420LUIACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT
SULISOBENZONE1W6L629B4KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
WATER059QF0KO0RIACT

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
Fruit of the Earth Cool Blue Aloe Mist ContinuousLIDOCAINE HYDROCHLORIDEFruit Of The Earth, Inc.d4caae4c-efba-2453-e053-2995a90a5e5f2024-10-18WarningsExact identifier
ndc (package): 62217-095-25
ndc (product): 62217-095
ndc11 (package): 62217009525
spl id: 24c784b5-a8b3-d355-e063-6394a90a337e
spl set id: d4caae4c-efba-2453-e053-2995a90a5e5f

Reported adverse events (FAERS/openFDA)#

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