FDA.reportPublic FDA data

RAPID PAIN-RELIEF TOPICAL CREAM

Manufacturer
NORDIC HEALTHY LIVING INC.
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:03

Label at a glance#

ProductRAPID PAIN-RELIEF TOPICAL
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL
Label structure9 sections

Indications and uses

For the temporary relief of pain.

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 HCL 4.00% Menthol 1.00%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain.

Warnings:

WARNINGS SECTION

not intended for ingestion. For external use only

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

Condition worsens, or if symptoms persist for 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, get medical help, or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 at 20-25°C (68-77°F) and protect from moisture.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Ascorbic Acid (Vitamin C), Boswellia Serrata Extract, Caprylic/Capric Triglyceride, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis (Yerba Mate’) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Methyl salicylate, Phenoxyethanol, Potassium Hydroxide.

Questions?

OTC - QUESTIONS SECTION

(800) 564-1408

Package Labeling: RAPID PAIN-RELIEF TOPICAL CREAM, 2oz/60ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label01Label01

Package Labeling: RAPID PAIN-RELIEF TOPICAL CREAM, 6oz/175ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label02Label02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1595624lidocaine HCl 4 % / menthol 1 % Topical CreamPSN2
1595624lidocaine hydrochloride 40 MG/ML / menthol 10 MG/ML Topical CreamSCD2
1595624lidocaine hydrochloride 4 % / menthol 1 % Topical CreamSY2

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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
82798-295-02RAPID PAIN-RELIEF TOPICAL60 mL in 1 TUBECREAM602
82798-295-06RAPID PAIN-RELIEF TOPICAL175 mL in 1 TUBECREAM1752

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82798-295RAPID PAIN-RELIEF TOPICAL (LIDOCAINE HYDROCHLORIDE, MENTHOL) CREAM [NORDIC HEALTHY LIVING INC.]2Current NDC, Legacy NDC, 2 package rows20231106_a06d6aca-9aa2-4bbe-bf77-4c85f1dd7870.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82798-29582798-295-02, 82798-295-06

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
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
METHYL SALICYLATELAV5U5022YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MENTHOLL7T10EIP3AACTIB

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
RAPID PAIN-RELIEF TOPICALLIDOCAINE HYDROCHLORIDE, MENTHOLNORDIC HEALTHY LIVING INC.a06d6aca-9aa2-4bbe-bf77-4c85f1dd78702023-11-06WarningsExact identifier
ndc (package): 82798-295-06
ndc (package): 82798-295-02
ndc (product): 82798-295
ndc11 (package): 82798029506
ndc11 (package): 82798029502
spl id: 0976fa2b-1b10-140f-e063-6394a90a72a5
spl set id: a06d6aca-9aa2-4bbe-bf77-4c85f1dd7870

Reported adverse events (FAERS/openFDA)#

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