FDA.reportPublic FDA data

Relief Balm

Manufacturer
Dr.Sankunni's Ayurvedic Research Foundation Private Limited
Effective date
2021-06-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:40:43

Label at a glance#

ProductRelief Balm
Active ingredientCAMPHOR (NATURAL), EUCALYPTUS OIL, MENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Uses:  Temporarily relieves minor aches & pains related to

  • arthritis
  • backaches
  • bursitis
  • sore muscles
  • joint pain
  • leg cramps
  • bruises
  • sprains

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental ingestion.

If swallowed, get medical help or contact a poison control center immediately.

INDICATIONS & USAGE SECTION

ZEN

for aches & pains

all natural relief balm coconut oil

ideal for:

aches & pains related to

rheumatoid arthritis

joint pain

backaches

bursitis

sore muscles

arthritis

leg cramps

sprains and strains

DOSAGE & ADMINISTRATION SECTION

Directions:

  • use only as directed
  • apply generously to affected area 3 to 4 times daily
  • children under 12, consult a doctor before use.

WARNINGS SECTION

WARNINGS For external use only

When using this product

  • discontinue use if excessive irritation of the skin develops
  • avoid contact with eyes and mucus membranes
  • do not bandage tightly
  • do not use with heating pad

Stop use and ask a doctor if

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients

coconut oil, paraffin wax, white petroleum jelly, light liquid paraffin, beeswax, clove oil, nutmeg oil, cassia oil, cinnamon oil, peppermint oil, borneol, citronella oil

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Camphor 11% Topical Analgesic

Eucalyptus Oil 10% Anti-Inflammatory

Menthol 8% Topical Analgesic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1855728camphor 11 % / eucalyptus oil 10 % / menthol 8 % Topical CreamPSN3
1855728camphor 110 MG/ML / Eucalyptus oil 100 MG/ML / menthol 80 MG/ML Topical CreamSCD3
1855728camphor 11 % / eucalyptus oil 10 % / menthol 8 % Topical CreamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70146-004-012024-01-30C16284748780-1ba0f9c33-3681-a910-e053-dadaa90a0b85382684d6-9a86-741f-e054-00144ff8d46c
70146-004-022024-01-30C16284748780-1ba0f9c33-3681-a910-e053-dadaa90a0b85382684d6-9a86-741f-e054-00144ff8d46c
70146-004-012021-06-04C16284748780-1ba0f9c33-3681-a910-e053-dadaa90a0b85382684d6-9a86-741f-e054-00144ff8d46c
70146-004-022021-06-04C16284748780-1ba0f9c33-3681-a910-e053-dadaa90a0b85382684d6-9a86-741f-e054-00144ff8d46c
70146-004-012021-01-29C16284748780-1ba0f9c33-3681-a910-e053-dadaa90a0b85382684d6-9a86-741f-e054-00144ff8d46c
70146-004-022021-01-29C16284748780-1ba0f9c33-3681-a910-e053-dadaa90a0b85382684d6-9a86-741f-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70146-004-01Relief Balm5 g in 1 JARCREAM53
70146-004-02Relief Balm20 g in 1 JARCREAM203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70146-004RELIEF BALM (CAMPHOR, EUCALYPTUS OIL, MENTHOL) CREAM [DR.SANKUNNI'S AYURVEDIC RESEARCH FOUNDATION PRIVATE LIMITED]3Legacy NDC, 2 package rows20210605_382684d6-9a86-741f-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70146-00470146-004-01, 70146-004-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCONUT OILQ9L0O73W7LIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
LIGHT MINERAL OILN6K5787QVPIACT
YELLOW WAX2ZA36H0S2VIACT
CLOVE OIL578389D6D0IACT
NUTMEG OILZ1CLM48948IACT
CHINESE CINNAMON OILA4WO0626T5IACT
PEPPERMINT OILAV092KU4JHIACT
BORNEOLM89NIB437XIACT
CITRONELLA OILQYO8Q067D0IACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
EUCALYPTUS OIL2R04ONI662ACTIB
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
c3f340c0-6241-0f00-e053-2a95a90a9914382684d6-9a86-741f-e054-00144ff8d46c2021-06-04WarningsExact identifier
spl id: c3f340c0-6241-0f00-e053-2a95a90a9914
spl set id: 382684d6-9a86-741f-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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