FDA.reportPublic FDA data

Rhulief Pain Relieving Balm

Manufacturer
EuroPharma, Inc
Effective date
2019-10-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:05:59

Label at a glance#

ProductRhulief Pain Relieving Balm
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, stains, bruises, and sprains.

Dosage and administration

Adults and children 12 years of age and older. Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: Consult a physician.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.30%

Camphor 3.50%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, stains, bruises, and sprains.

Warnings

WARNINGS SECTION

  • For esternal use only.
  • Avoid contact with the eyes.
  • Do not bandage tightly or use hearing pad.
  • Do not apply to open wounds or damaged skin.

Discontinue use of this product and consult a physician

OTC - ASK DOCTOR SECTION

if condition worsens, symptons persist for more than 7 days, or excessive skin irrirtation occurs.

Keep our of the reach of childre.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contct a Poison control Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older.

Apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: Consult a physician.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Beeswax, Boswellia(Boswellia Serrata) Gum Resin Extract, Coconut (Cocos Nucifera) Fuit Oil, Eucalyptus (Eucalyptus Globulus) Leaf Extract, Sesame (Sesamum Indicum) Seed Oil.

Rhulief Pain Relieving Balm, 40g (67703-001-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

bottle labelbottle label

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67703-00167703-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BOSWELLIA SERRATA RESIN OIL5T1XCE6K8KIACT
COCONUT OILQ9L0O73W7LIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
SESAME SEED7Y1255HVXRIACT
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB

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
95c10c24-b5ca-864d-e053-2995a90a323549b12d66-26c6-263d-e054-00144ff88e882019-10-25WarningsExact identifier
spl id: 95c10c24-b5ca-864d-e053-2995a90a3235
spl set id: 49b12d66-26c6-263d-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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