FDA.reportPublic FDA data

EXTERNAL ANALGESIC

Manufacturer
Hmong 21
Effective date
2023-12-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:05:41

Label at a glance#

ProductEXTERNAL ANALGESIC
Active ingredientCAMPHOR (SYNTHETIC), CAPSAICIN, MENTHOL
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with -simple backache -arthritis -strains -bruises -sprains

Dosage and administration

Adults and children 12 years of age and older: -Clean and dry affected area. -Remove from backing film and apply. -Remove from the skin after at most 8 hours' application. -Apply to the affected area not more than 3 times daily. -Children under 12 years of age: Consult a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 9.6%

Capsaicin 0.05%

Menthol 7.8%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with

-simple backache

-arthritis

-strains

-bruises

-sprains

Warnings

WARNINGS SECTION

When using this product

-avoid contact with the eyes

- do not apply to wounds or damaged skin

-do not bandage tightly

Stop use and ask a doctor if

- condition worsens

-if synthoms oersust for more than 7 days or clear up and occur again within a few days

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:

-Clean and dry affected area.

-Remove from backing film and apply.

-Remove from the skin after at most 8 hours' application.

-Apply to the affected area not more than 3 times daily.

-Children under 12 years of age: Consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2-ethylhexylacrylate, Glycerin, Methyl Acrylate, Polyacrylate, polyacrylic Acid, sodium polyacrylatem, Tartaric Acid, Water.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1807136camphor 9.6 % / capsaicin 0.05 % / menthol 7.8 % Medicated PatchPSN5
1807136camphor 0.096 MG/MG / capsaicin 0.0005 MG/MG / menthol 0.078 MG/MG Medicated PatchSCD5
1807136camphor 9.6 % / capsaicin 0.05 % / menthol 7.8 % Medicated PatchSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70927-001-00EXTERNAL ANALGESIC4 g in 1 PATCHPATCH45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70927-001EXTERNAL ANALGESIC (CAMPHOR, CAPSICUM, MENTHOL) PATCH [HMONG 21]5Current NDC, Legacy NDC, 1 package rows20231227_3b6155a5-51aa-2780-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70927-00170927-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
GLYCERINPDC6A3C0OXIACT
METHYL ACRYLATEWC487PR91HIACT
TARTARIC ACIDW4888I119HIACT
WATER059QF0KO0RIACT
CAPSICUM00UK7646FGIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
CAPSAICINS07O44R1ZMACTIB
MENTHOLL7T10EIP3AACTIB

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
EXTERNAL ANALGESICCAMPHOR, CAPSICUM, MENTHOLHmong 213b6155a5-51aa-2780-e054-00144ff8d46c2023-12-26WarningsExact identifier
ndc (package): 70927-001-00
ndc (product): 70927-001
ndc11 (package): 70927000100
spl id: 0d774b08-e5e4-56c9-e063-6294a90ae8db
spl set id: 3b6155a5-51aa-2780-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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