FDA.reportPublic FDA data

Caring mill Lidocaine Aloe Gel Burn and Pain Relief

Manufacturer
FSA Store Inc.
Effective date
2024-01-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:37

Label at a glance#

ProductCaring mill Lidocaine Aloe Gel Burn and Pain Relief
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

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

Dosage and administration

Adults and children 2 years of age and older. Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 0.5%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only
Avoidcontact with eyes
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again with a few days, discontinue use of this product and consult a doctor.

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or blistered areas.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

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. Children under 2 years of age: Consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

Store between 68°F to 77°F (20°C to 25°). May stain some fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Aloe Barbadensis Leaf Extract, Glycerin, Sodium Hydroxide, Propylene Glycol, Glyceryl Acrylate/Acrylic Acid Copolymer, Carbomer, Phenoxyethanol, Polysorbate 20, Caprylyl Glycol, Allantoin, Panthenol, Citrus Limon (Lemon) Peel Extract, Mentha Viridis (Spearmint) Leaf Oil, Symphytum Officinale (Comfrey) Leaf Extract, Tocopheryl Acetate, 1,2-Hexanediol, Ethylhexylglycerin, Blue 1, Yellow 5.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1011849lidocaine HCl 0.5 % Topical GelPSN1
1011849lidocaine hydrochloride 0.005 MG/MG Topical GelSCD1
1011849lidocaine hydrochloride 0.5 % Topical GelSY1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81522-953-01Caring mill Lidocaine Aloe Gel Burn and Pain Relief237 mL in 1 BOTTLELIQUID2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81522-953CARING MILL LIDOCAINE ALOE GEL BURN AND PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) LIQUID [FSA STORE INC.]1Current NDC, 1 package rows20240120_0ec20c87-1681-dd23-e063-6394a90a291c.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81522-95381522-953-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALLANTOIN344S277G0ZIACT
PANTHENOLWV9CM0O67ZIACT
LEMON PEEL72O054U628IACT
SPEARMINT OILC3M81465G5IACT
SYMPHYTUM X UPLANDICUM LEAFD05HXK6R3GIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
Caring mill Lidocaine Aloe Gel Burn and Pain ReliefLIDOCAINE HYDROCHLORIDEFSA Store Inc.0ec20c87-1681-dd23-e063-6394a90a291c2024-01-12WarningsExact identifier
ndc (package): 81522-953-01
ndc (product): 81522-953
ndc11 (package): 81522095301
spl id: 0ec20c87-1682-dd23-e063-6394a90a291c
spl set id: 0ec20c87-1681-dd23-e063-6394a90a291c

Reported adverse events (FAERS/openFDA)#

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