FDA.reportPublic FDA data

Womens Sports 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#

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients   Purpose

Camphor 11%                                           Topical Analgesic

Eucalyptus Oil 10%                                    Anti-Inflammatory

Menthol 8%                                               Topical Analgesic

Wintergreen Oil (Methyl Salicylate) 10%     Topical Analgesic

OTC - PURPOSE SECTION

Uses:  Temporarily relieves minor aches & pains in muscles and joints related to

  • strains
  • menstrual cramps
  • mild migraines
  • sprains
  • bruises
  • backaches
  • arthritis
  • sports and other minor injuries

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.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

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

INDICATIONS & USAGE SECTION

ZEN

for aches & pains

women's sports balm lavender oil

ideal for:

aches & pains related to

sports injuries

minor arthritis

sore muscles

leg cramps

cramps

strains and sprains

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

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
70146-007-012024-01-30C16284748780-1ba0f9c33-551f-a910-e053-dadaa90a0b85Womens Sports Balm
70146-007-022024-01-30C16284748780-1ba0f9c33-551f-a910-e053-dadaa90a0b85Womens Sports Balm
70146-007-012021-06-04C16284748780-1ba0f9c33-551f-a910-e053-dadaa90a0b85Womens Sports Balm
70146-007-022021-06-04C16284748780-1ba0f9c33-551f-a910-e053-dadaa90a0b85Womens Sports Balm
70146-007-012021-01-29C16284748780-1ba0f9c33-551f-a910-e053-dadaa90a0b85Womens Sports Balm
70146-007-022021-01-29C16284748780-1ba0f9c33-551f-a910-e053-dadaa90a0b85Womens Sports Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70146-007-01Womens Sports Balm5 g in 1 JARCREAM53
70146-007-02Womens Sports Balm20 g in 1 JARCREAM203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70146-007WOMENS SPORTS BALM (CAMPHOR, EUCALYPTUS OIL, MENTHOL) CREAM [DR.SANKUNNI'S AYURVEDIC RESEARCH FOUNDATION PRIVATE LIMITED]3Legacy NDC, 2 package rows20210605_38270beb-fa4a-67cf-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70146-00770146-007-01, 70146-007-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
LIGHT MINERAL OILN6K5787QVPIACT
YELLOW WAX2ZA36H0S2VIACT
CLOVE OIL578389D6D0IACT
NUTMEG OILZ1CLM48948IACT
CHINESE CINNAMON OILA4WO0626T5IACT
CINNAMON OILE5GY4I6YCZIACT
PEPPERMINT OILAV092KU4JHIACT
BORNEOLM89NIB437XIACT
CITRONELLA OILQYO8Q067D0IACT
LAVENDER OILZBP1YXW0H8IACT
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
c3f3546f-9773-95fb-e053-2995a90acc9938270beb-fa4a-67cf-e054-00144ff88e882021-06-04WarningsExact identifier
spl id: c3f3546f-9773-95fb-e053-2995a90acc99
spl set id: 38270beb-fa4a-67cf-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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