Active Ingredients And Purpose
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
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
Key Label Information#
Uses
INDICATIONS & USAGE SECTION
Uses Temporary relief of: • pain • itching associated with: ▪ minor burns ▪ sunburn ▪ minor cuts ▪ scrapes ▪ insect bites ▪ minor skin irritations
Warnings
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
Directions And Dosage
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.
Other Label Information
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
Label Images#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 070fbed5-7088-434a-a7ce-f2a64d8d40ac | Product name | 2 | 20260107 |
| bee66ce1-adb7-9d3b-67d9-582e4c54e80f | Product name | 5 | 20250819 |
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| eaba870a-6a9d-442e-8643-87b3f558a451 | Product name | 1 | 20250117 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| 7d755fa1-1087-4dcd-98f0-6d4bba479a57 | Product name | 3 | 20210602 |
| aed701d5-9c75-dfaf-7154-cde46179faea | Product name | 9 | 20200313 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| 332d03e4-aa24-4b11-841a-02bf41081920 | Product name | 1 | 20171221 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
| 49fa150c-f0de-cce7-3d9c-993ed81c5698 | Product name | 1 | 20140508 |
| 4d7ae718-ed00-bae8-2abe-9eaec1eef7ff | Product name | 1 | 20140508 |
| 9137811f-f279-8640-5aeb-99fa2145d64d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72042-001-01 | Pain Relief | 70873.8 mg in 1 TUBE | CREAM | 70873.8 | 2 | |
| 72042-001-01 | Pain Relief | 1 in 1 CARTON | CREAM | 1 | 2 | |
| 72042-001-03 | Pain Relief | 1 in 1 CARTON | CREAM | 1 | 2 | |
| 72042-001-03 | Pain Relief | 28349.5 mg in 1 TUBE | CREAM | 28349.5 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
- Pain Relief
- Lidocaine, Menthol
- LIDOCAINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72042-001 | 72042-001-01, 72042-001-03 |
Ingredients#
Complete SPL Sections#
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