Fruit of the Earth Cool Blue Aloe Mist Continuous Spray

Manufacturer
Fruit Of The Earth, Inc. | Fruit Of The Earth Research Laboratories, Inc.
Effective date
2019-11-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:00:46

Label at a glance#

ProductFruit of the Earth Cool Blue Aloe Mist Continuous
Active ingredientLIDOCAINE
Label structure11 sections

Indications and uses

For the temporary relief of sunburn, minor burns, scrapes, insect bites, minor rashes, minor skin irritations and windburned skin.

Dosage and administration

Adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily Spray on hands to apply to face. Use in a well-ventilated area. Children under 2 years of age, ask a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine (1.0%)

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of sunburn, minor burns, scrapes, insect bites, minor rashes, minor skin irritations and windburned skin.

Warnings

WARNINGS SECTION

  • EXTERNAL USE ONLY
  • Do not use near heat, flame or while smoking. Avoid long term storage above 104°F (40°C).
  • Do not spray directly in eyes or face.
  • May stain some fabrics.

OTC - DO NOT USE SECTION

​Do not use ​in large quantities, particularly over raw surfaces or blistered areas

  • Do not use on puncture wounds

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes and eyelids. If contact with eyes occurs, 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, or if symptoms persist more than 7 days or 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; apply to affected area not more than 3 to 4 times daily
  • Spray on hands to apply to face.
  • Use in a well-ventilated area.
  • Children under 2 years of age, ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Fruit of the Earth Cool Blue Aloe Mist Continuous Spray 177 mL NDC: 62217-201-20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI2009871
LIDOCAINEACTIVE MOIETY98PI2009871
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27E1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
ISOCETETH-20INACTIVE INGREDIENTO020065R7Z1
MAGNESIUM NITRATEINACTIVE INGREDIENT77CBG3UN781
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SAB1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPN1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA1
SULISOBENZONEINACTIVE INGREDIENT1W6L629B4K1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62217-20162217-201-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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 2 · 86 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL, METERED / TRANSDERMAL50 mgExact identifier — unii candidate
9 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCREAM / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii candidate
9 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / SUBLINGUAL0.03 mgExact identifier — unii candidate
37 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSPONGE / TOPICAL0.14 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDMOUTHWASH / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii candidate
37 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUCAPSULE / ORAL1 mgExact identifier — unii candidate
12 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABTABLET, COATED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / OPHTHALMIC4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii candidate
37 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABTABLET / ORAL2.9 mgExact identifier — unii candidate
6 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDDOUCHE / VAGINALNAExact identifier — unii candidate
37 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL, METERED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
9 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSPONGE / TOPICAL11 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii candidate
9 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM, SOLUBLE / ORAL0.04 mgExact identifier — unii candidate
37 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUEMULSION / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABSOAP / TOPICAL0.2 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EOINTMENT, AUGMENTED / TOPICAL23 mgExact identifier — unii candidate
9 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABCAPSULE / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUINJECTION / INTRAMUSCULAR0.01 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
37 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUINJECTION / INTRAVENOUS0.01 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABTABLET, FILM COATED / ORAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOAP / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
37 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKPOWDER / TOPICAL0.02 mg/mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLOTION / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LULOTION / TOPICAL0.17 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ELOTION / TOPICAL300 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
d4cba05a-399b-5e08-e053-2995a90afc14aa39c75e-5efb-435b-95ab-a41cfc36e4f22022-01-04WarningsExact identifier
spl set id: aa39c75e-5efb-435b-95ab-a41cfc36e4f2

Reported adverse events (FAERS/openFDA)#

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