FDA.reportPublic FDA data

TopCare Everyday After Sun Cooling Gel

Manufacturer
TOPCO ASSOCIATES LLC
Effective date
2024-10-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:25:50

Label at a glance#

ProductTopCare Everyday After Sun Cooling
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

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

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: ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine hydrochloride 0.5%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to:

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

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 contact with eyes. If contact occurs, rinse with water to remove.

Stop use and ask a doctor if

OTC - ASK DOCTOR 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

  • 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: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, water, isopropyl alcohol, propylene glycol, glycerin, triethanolamine, carbomer, polysorbate 80, diazolidinyl urea, menthol, disodium EDTA, yellow 5, blue 1

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare Everyday After Sun Cooling Gel

8 OZ (226 g)

NDC 36800-953-80

TOP45898E1F1TOP45898E1F1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1011849lidocaine HCl 0.5 % Topical GelPSN2
1011849lidocaine hydrochloride 0.005 MG/MG Topical GelSCD2
1011849lidocaine hydrochloride 0.5 % Topical 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
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
36800-953-80TopCare Everyday After Sun Cooling226 g in 1 BOTTLEGEL2262

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-953TOPCARE EVERYDAY AFTER SUN COOLING (LIDOCAINE HYDROCHLORIDE) GEL [TOPCO ASSOCIATES LLC]2Current NDC, Legacy NDC, 1 package rows20241017_baff7293-e1a3-d1f2-e053-2995a90a93ca.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-95336800-953-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
TROLAMINE9O3K93S3TKIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
POLYSORBATE 806OZP39ZG8HIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE DISODIUM7FLD91C86KIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
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
TopCare Everyday After Sun CoolingLIDOCAINE HYDROCHLORIDETOPCO ASSOCIATES LLCbaff7293-e1a3-d1f2-e053-2995a90a93ca2024-10-15WarningsExact identifier
ndc (package): 36800-953-80
ndc (product): 36800-953
ndc11 (package): 36800095380
spl id: 24882cf3-66aa-4a61-e063-6394a90a63b5
spl set id: baff7293-e1a3-d1f2-e053-2995a90a93ca

Reported adverse events (FAERS/openFDA)#

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