Pain Relief Hot Patch

Manufacturer
Universal Distribution Center LLC | Zhejiang Dingtai Pharmaceutical Co., Ltd
Effective date
2020-02-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:41:22

Label at a glance#

ProductPain Relief Hot Patch
Active ingredientMENTHOL, UNSPECIFIED FORM, CAPSAICIN
Label structure9 sections

Indications and uses

Temporarily relieves minor pains associated with: arthritis • simple backache • bursitis • tendonitis • muscle strains • bruises • cramps

Dosage and administration

Adults and Children 12 years of age and older: Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions Apply to affected area not more than 3 to 4 times a daily Children under 12 years of age: DO NOT use without consulting a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 30 mg

Capsaicin 8.3 mg

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pains associated with:

  • arthritis • simple backache • bursitis • tendonitis • muscle strains • bruises • cramps

WARNINGS:

WARNINGS SECTION

EXTERNAL USE ONLY

When using this product

• USE ONLY AS DIRECTED • do not bandage tightly or use with a heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin.

STOP USE and ask a doctor if

• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days

• redness is present • skin irritation develops

If pregnant or breast-feeding, ask a health professional before use.

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 (1-800-222-1222) immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and Children 12 years of age and older:

  • Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions
  • Apply to affected area not more than 3 to 4 times a daily

    Children under 12 years of age: DO NOT use without consulting a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

glycerin, sodium polyacrylate, aluminum glycinate, kaolin, methylparaben, propylparaben, alcohol, titanium dioxide, tartaric acid, sorbitan monooleate, polysorbate 80, purified water

SPL UNCLASSIFIED SECTION

EXTRA STRENGTH PAIN RELIEF HOT PATCH soothes and relieves pain associated with minor aches and pains. It is ideal for small areas such as arm, neck and leg.

Distributed by:

Universal Distribution Center

96 Distribution Boulevard • Edison, NJ 08817

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52000-03452000-034-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
05d9a640-5aa2-42f1-a019-a906c07a80d4b291eb62-a68e-444c-b409-8b5a6e6d23d72020-04-10WarningsExact identifier
spl set id: b291eb62-a68e-444c-b409-8b5a6e6d23d7

Reported adverse events (FAERS/openFDA)#

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