FDA.reportPublic FDA data

HERBAL

Manufacturer
Albert Max, Inc.
Effective date
2018-12-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:39:37

Label at a glance#

ProductHERBAL PAIN RELIEVING
Active ingredientMENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, CAMPHOR (NATURAL)
Label structure9 sections

Indications and uses

Temporarily relieves minor muscle and joint pain due to: • simple backache • arthritis • strains • bruises • sprains

Dosage and administration

Adult and children 2 years and over: apply to affected area not more than 3 to 4 times daily. Children under 2 years: ask a doctor 

Label contents#

Full prescribing information#

​Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

Methyl Salicylate 40%

Camphor 10%

Purpose​

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor muscle and joint pain due to:
• simple backache • arthritis • strains • bruises • sprains

​Warnings

WARNINGS SECTION

​DO NOT USE if pregnant or breast-feeding.

For external use only

When using this product

  • use only as directed
  • do not get into the eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop use and ask a doctor if:

  • Excessive irritation develops
  • Pain worsens or does not improve within 7 days or clears up and appears again in a few days.

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

  • Adult and children 2 years and over: apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years: ask a doctor 

Inactive ingredient

INACTIVE INGREDIENT SECTION

Eucalyptus Oil, Lavender Oil

SPL UNCLASSIFIED SECTION

Distributed by

America Health Herbs, Inc.

15361 Brookhurst #104

Westminster, CA 93683

Tel 1-888-811-1133

Fax 1-714-531-2010

Made in Taiwan   

​Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68233-809-012023-10-10C16284748780-19d75b9d0-1cba-f424-e053-dadaa90a57ceHERBAL OIL- Pain Relieving Oil
68233-809-012020-01-31C16284748780-19d75b9d0-1cba-f424-e053-dadaa90a57ceHERBAL OIL- Pain Relieving Oil

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68233-80968233-809-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS OIL2R04ONI662IACT
LAVENDER OILZBP1YXW0H8IACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
CAMPHOR (NATURAL)N20HL7Q941ACTIB

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
07575a7d-b468-7abc-e063-6294a90ab0fdf1fd64d3-8f8f-4814-a9e6-f1cd166748d32023-10-10WarningsExact identifier
spl set id: f1fd64d3-8f8f-4814-a9e6-f1cd166748d3

Reported adverse events (FAERS/openFDA)#

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