Pain Relief Cream TPR 20

Manufacturer
HUMN Pharmaceuticals Inc | Delta Pharma Inc | Delta Pharma Inc.
Effective date
2024-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:29

Label at a glance#

ProductPain Relief
Active ingredientMENTHOL, LIDOCAINE HYDROCHLORIDE ANHYDROUS
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Lidocaine Hydrochloride 4.0% (w/w)

Menthol 1.0% (w/w)

OTC - PURPOSE SECTION

Purpose

Anesthetic

Analgesic, anesthetic, and antipruritic

INDICATIONS & USAGE SECTION

Uses

Temporary relief of:

• pain

• itching associated with:

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

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use

• in large quantities • over large areas of the body • over raw surfaces • over blistered areas

OTC - ASK DOCTOR SECTION

Ask a doctor before use

if child is under 2 years of age, and use only as directed

OTC - WHEN USING SECTION

When using this product

• avoid contact with eyes; if this happens, rinse thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctor

• condition worsens • if symptoms persist for more than 7 days

• clear up and occur again within a few days • you experience: pain, swelling, or blistering

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get

medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

INFORMATION FOR PATIENTS SECTION

Other information

• do not use if seal is broken

• store at 60-85° F

INACTIVE INGREDIENT SECTION

Inactive ingredients

Acrylates/Acrylamide Copolymer, Allantoin, Alpha-Lipoic Acid, Beeswax, Butylene Glycol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceteraryl Alcohol, Ceteth-20, Ceteth-10 Phosphate, Denatured Alcohol, Dicetyl Phosphate, Dimethicone, Glycerin, Glyceryl Stearate, Iodopropynyl Butylcarbamate, Isopropyl Myristate, Laureth-7, Lecithin, Mineral Oil, PEG-6 Stearate, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate 85, Purified Water, Steareth-2, Steareth-20, Steareth-21.

OTC - QUESTIONS SECTION

Questions?

1-866-335-3596 Monday to Friday 8 am to 6 pm EST .

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TPR20 Pain Relief Label

TPR Pain Relief LabelTPR Pain Relief Label

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
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
72042-001-01Pain Relief70873.8 mg in 1 TUBECREAM70873.82
72042-001-01Pain Relief1 in 1 CARTONCREAM12
72042-001-03Pain Relief1 in 1 CARTONCREAM12
72042-001-03Pain Relief28349.5 mg in 1 TUBECREAM28349.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72042-001PAIN RELIEF (LIDOCAINE, MENTHOL) CREAM [HUMN PHARMACEUTICALS INC]2Current NDC, Legacy NDC, 4 package rows20240118_6c96f94a-e724-eab3-e053-2991aa0aab88.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72042-00172042-001-01, 72042-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

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
Pain ReliefLIDOCAINE, MENTHOLHUMN Pharmaceuticals Inc6c96f94a-e724-eab3-e053-2991aa0aab882024-01-17WarningsExact identifier
ndc (package): 72042-001-03
ndc (package): 72042-001-01
ndc (product): 72042-001
ndc11 (package): 72042000101
ndc11 (package): 72042000103
spl id: 0f2c6727-1dbd-8ad5-e063-6294a90af0be
spl set id: 6c96f94a-e724-eab3-e053-2991aa0aab88

Reported adverse events (FAERS/openFDA)#

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