Pain Relief Cream Tpr 20

Pain Relief Cream Tpr 20
SPL v2
SPL
SPL Set ID 6c96f94a-e724-eab3-e053-2991aa0aab88
Route
TOPICAL
Published
Effective Date 2018-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 mg) Lidocaine (4 mg)
Inactive Ingredients
Ceteth-20 Alcohol Aluminum Dicetyl Phosphate Glycerin Mineral Oil Peg-6 Stearate Peg-100 Stearate Polyacrylamide (10000 Mw) Steareth-2 Steareth-20 Ceteth-10 Phosphate Peg-120 Glyceryl Stearate Iodopropynyl Butylcarbamate Isopropyl Myristate Laureth-7 Lecithin, Soybean Phenoxyethanol Dimethicone 100 Polysorbate 85 Water Caprylyl Glycol Caprylic/capric/lauric Triglyceride C13-14 Isoparaffin Acrylamide Cetyl Alcohol Yellow Wax Butylene Glycol Alkyl (c12-15) Benzoate Allantoin .alpha.-lipoic Acid Steareth-21

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-05-19
Description

Active ingredients Lidocaine Hydrochloride 4.0% (w/w) Menthol 1.0% (w/w)

Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

Temporary relief of:

• pain

• itching associated with:

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

Dosage and Administration

Directions

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

Description

Active ingredients Lidocaine Hydrochloride 4.0% (w/w) Menthol 1.0% (w/w)

Section 34076-0

Other information

• do not use if seal is broken

• store at 60-85° F

Section 50565-1

Keep out of reach of children. If swallowed, get

medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

When using this product

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

Section 50569-3

Ask a doctor before use

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

Section 50570-1

Do not use

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

Section 51727-6

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.

Section 51945-4

TPR20 Pain Relief Label

Section 53413-1

Questions?

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

Section 55105-1

Purpose

Anesthetic

Analgesic, anesthetic, and antipruritic

Section 55106-9

Active ingredients

Lidocaine Hydrochloride 4.0% (w/w)

Menthol 1.0% (w/w)

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporary relief of:

• pain

• itching associated with:

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

Dosage and Administration (34068-7)

Directions

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

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 34076-0 (34076-0)

Other information

• do not use if seal is broken

• store at 60-85° F

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get

medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

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

Section 50569-3 (50569-3)

Ask a doctor before use

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

Section 50570-1 (50570-1)

Do not use

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

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

TPR20 Pain Relief Label

Section 53413-1 (53413-1)

Questions?

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

Section 55105-1 (55105-1)

Purpose

Anesthetic

Analgesic, anesthetic, and antipruritic

Section 55106-9 (55106-9)

Active ingredients

Lidocaine Hydrochloride 4.0% (w/w)

Menthol 1.0% (w/w)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:42.641600 · Updated: 2026-03-14T23:02:24.469183