FDA.reportPublic FDA data

Solarcaine Burn Pain Relief 4oz

Manufacturer
WellSpring Pharmaceutical Corporation
Effective date
2024-06-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:51:24

Label at a glance#

ProductSolarcaine Burn Pain Relief 4oz
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves pain and itching due to: sunburn minor burns minor cuts scrapes insect bites minor skin irritations

Dosage and administration

shake well 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: do not use, ask a doctor to apply to face, spray in palm of hand and gently apply

Label contents#

Full prescribing information#

Active Ingredients (w/w)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Purpose 

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to:

  • sunburn
  • minor burns
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations

Warnings

WARNINGS SECTION

For external use only. When using this product

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. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • do not puncture or incinerate. Contents under pressure. Avoid prolonged storage above 40°C (104°F).

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition gets worse
  • symptoms last more than 7 days
  • symptoms clear up and occur again in a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well
  • 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: do not use, ask a doctor
  • to apply to face, spray in palm of hand and gently apply

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, propylene glycol, aloe barbadensis leaf juice, polysorbate 80, ethylhexylglycerin, tocopheryl acetate (vitamin E acetate), 2-phenoxyethanol, sodium hydroxide

Questions?

OTC - QUESTIONS SECTION

1-844-241-5454  

Distributed by:

SPL UNCLASSIFIED SECTION

Distributed by:

WellSpring Pharmaceutical Corporation
Sarasota, FL 34243

© 2024 WellSpring Pharmaceutical Corporation
MONEY BACK GUARANTEE

Solarcaine is FSA/HSA eligible

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 Pharmacist Recommended*

* Pharmacy Times/* U.S News & World

Report 2023-2024

DOT 2Q M5706

L50210A | B6526

CONTAINS NO CFCs WHICH
DEPLETE THE OZONE LAYER

Solarcaine After sun pain relief
Solarcaine After sun pain relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1045432lidocaine HCl 4 % Topical SprayPSN2
1045432lidocaine hydrochloride 40 MG/ML Topical SpraySCD2
1045432lidocaine HCl 4 % Topical SpraySY2
1045432lidocaine HCl 4 % Topical Spray GelSY2

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
65197-512-04Solarcaine Burn Pain Relief 4oz113 g in 1 CANSPRAY1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-512SOLARCAINE BURN PAIN RELIEF 4OZ (SOLARCAINE BURN PAIN RELIEF 4OZ) SPRAY [WELLSPRING PHARMACEUTICAL CORPORATION]2Current NDC, 1 package rows20250110_2c0389db-ceb2-422b-9575-bdb8fe649a1e.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
65197-51265197-512-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
SODIUM HYDROXIDE55X04QC32IIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYSORBATE 806OZP39ZG8HIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
Solarcaine Burn Pain Relief 4ozSOLARCAINE BURN PAIN RELIEF 4OZWellSpring Pharmaceutical Corporation2c0389db-ceb2-422b-9575-bdb8fe649a1e2024-06-26WarningsExact identifier
ndc (package): 65197-512-04
ndc (product): 65197-512
ndc11 (package): 65197051204
spl id: 6c821db0-8d38-4fd0-ad6e-7215f7b1cd83
spl set id: 2c0389db-ceb2-422b-9575-bdb8fe649a1e

Reported adverse events (FAERS/openFDA)#

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