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

Key Label Information#

Active Ingredients And Purpose

Active Ingredient

Lidocaine hydrochloride 0.5%

Purpose

External Analgesic

Uses

Uses

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

Warnings

Warnings

For External Use Only

​Do not use

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

Stop use and ask a doctor if

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

Directions And Dosage

Directions

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

Other Label Information

Inactive Ingredients

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

Label

TopCare Everyday After Sun Cooling Gel 8 OZ (226 g) NDC 36800-953-80

Label Images#

TOP45898E1F1
TOP45898E1F1

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#

NDC Codes#

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

Ingredients#

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

Complete SPL Sections#

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

Source Document#

Source XML