FDA.reportPublic FDA data

Pain Relief Cream

Manufacturer
QINGDAO HAINUO BIOLOGICAL ENGINEERING CO., LTD.
Effective date
2023-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:04:14

Label at a glance#

ProductPain Relief Cream
Active ingredientMENTHOL
Label structure10 sections

Dosage and administration

For Use By Adults Only Apply generously to affected area. Massage into painful area until thoroughly absorbed into skin Repeat as necessary.Repeat up 4 times a day.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 2%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Use

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises

Warnings

WARNINGS SECTION

For external use only

Allergy alert:If prone to allergic reaction from aspirin or salicylates,consult a doctor before use.

Do not use

OTC - DO NOT USE SECTION

  • Do not bandage tightly or aooly local heat (such as heating pads) to the aera of use.
  • Avoid contact with eyes or mucous membranes.
  • Do not apply to wounds or damaged broken or irritated skin.
  • Do not use at the same time as other topical analgesics.

OTC - WHEN USING SECTION

Use only as directed.Read and follow all directions and warmings on this label.

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

OTC - STOP USE SECTION

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 or irritation develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed,get medical help or contact a Poison Contriol Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For Use By Adults Only
  • Apply generously to affected area.
  • Massage into painful area until thoroughly absorbed into skin
  • Repeat as necessary.Repeat up 4 times a day.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78149-205-012025-01-30C16284748780-10191ceaa-683f-198a-e063-dbdaa90aec3ePain Relief Cream
78149-205-012023-12-13C16284748780-10191ceaa-683f-198a-e063-dbdaa90aec3ePain Relief Cream
78149-205-012023-07-28C16284748780-10191ceaa-683f-198a-e063-dbdaa90aec3ePain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78149-205-01Pain Relief Cream100 g in 1 BOTTLESOLUTION1002
78149-205-01Pain Relief Cream1 in 1 PACKAGESOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78149-205PAIN RELIEF CREAM SOLUTION [QINGDAO HAINUO BIOLOGICAL ENGINEERING CO., LTD.]2Legacy NDC, 2 package rows20231214_6d87138f-5979-4e23-bd9e-ce96df1bd6f0.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78149-20578149-205-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ANGELICA SINENSIS ROOTB66F4574UGIACT
PAPAYAKU94FIY6JBIACT
MYRRHJC71GJ1F3LIACT
HERACLEUM HEMSLEYANUM WHOLEG3X356J02FIACT
HOMALOMENA OCCULTA ROOTPE3TAO734BIACT
BOSWELLIA SACRA WHOLE8O600AZL0WIACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
LAUROCAPRAM1F3X9DRV9XIACT
SQUALANEGW89575KF9IACT
WATER059QF0KO0RIACT

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
bb6812ef-8272-41a7-b1a1-3d522813b5e36d87138f-5979-4e23-bd9e-ce96df1bd6f02023-12-13WarningsExact identifier
spl id: bb6812ef-8272-41a7-b1a1-3d522813b5e3
spl set id: 6d87138f-5979-4e23-bd9e-ce96df1bd6f0

Reported adverse events (FAERS/openFDA)#

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