FDA.reportPublic FDA data

Ramedica Roll On

Manufacturer
Ramedicare Sdn. Bhd.
Effective date
2024-11-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:44:15

Label at a glance#

ProductRamedica Roll On
Active ingredientCAMPHOR (NATURAL), METHYL SALICYLATE, EUCALYPTUS OIL, MENTHOL
Label structure8 sections

Indications and uses

Temporarily relieves minor aches & pains related to sore muscles sore joints  neck pain  joint pain  headache

Dosage and administration

Roll generously to affected area 3-4 times daily Children under 12, consult a doctor before use.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor  10.8%

Wintergreen Oil (Methyl Salicylate) 0.2%

Eucalyptus Oil   7%

Menthol   11%

Purpose

OTC - PURPOSE SECTION

Camphor 10.8%................................Topical Analgesic
Eucalyptus Oil 7%...........................Anti-inflammatory
Menthol Crystal 11%.........................Topical Analgesic
Wintergreen 0.2%.............................Topical Analgesic
(Methyl Salicylate)

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches & pains related to

  • sore muscles
  • sore joints 
  • neck pain 
  • joint pain 
  • headache

Warnings

WARNINGS SECTION

For external use only.
When using this product: Discontinue use if excessive irritation of the skin develops. Avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not bandage tightly. Do not use with a heating pad.


Discontinue use of this product and consult a doctor if:

  • Condition worsens 
  • Symptoms persist for more than 7 days or clear up and occur again within a few days 
  • Severe skin irritation occurs

If pregnant or breast-feeding, ask a health care professional before use


Keep out of reach of children. If swallowed, get medical help or contact a Poison Control immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • Roll generously to affected area 3-4 times daily
  • Children under 12, consult a doctor before use.

Other information

SPL UNCLASSIFIED SECTION

Store in a cool dry place 20° to 25° C (68° to 77° F). This product may cause allergic reaction in some individuals. Test on small area before use. Do not use if seal is broken.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Borneol, Cassia Oil, Cinnamon Oil, Citronella Oil, Clove Oil, Coconut Oil, Light Liquid Paraffin, Narayani Oil, Nutmeg Oil, Peppermint Oil

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description
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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2672333camphor 10.8 % / eucalyptus oil 7 % / menthol 11 % / methyl salicylate 0.2 % Topical OilPSN2
2672333camphor 108 MG/ML / Eucalyptus oil 70 MG/ML / menthol 110 MG/ML / methyl salicylate 2 MG/ML Topical OilSCD2
2672333camphor 10.8 % / eucalyptus oil 7 % / menthol 11 % / methyl salicylate 0.2 % Topical OilSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66059-0003-1Ramedica Roll On12 in 1 CARTONOIL122
66059-0003-1Ramedica Roll On18 in 1 CASEOIL182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66059-0003RAMEDICA ROLL ON (CAMPHOR,EUCALYPTUS OIL,MENTHOL,WINTERGREEN (METHYL SALICYLATE)) OIL [RAMEDICARE SDN. BHD.]22 package rows20241219_89ddd2b4-2cec-4eb4-9ceb-30b723cf2264.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66059-000366059-0003-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BORNEOLM89NIB437XIACT
CHINESE CINNAMON OILA4WO0626T5IACT
CINNAMON OILE5GY4I6YCZIACT
CITRONELLA OILQYO8Q067D0IACT
CLOVE OIL578389D6D0IACT
COCONUT OILQ9L0O73W7LIACT
MINERAL OILT5L8T28FGPIACT
PEPPERMINT OILAV092KU4JHIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
METHYL SALICYLATELAV5U5022YACTIB
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
2736a25e-802d-cd18-e063-6394a90a07e789ddd2b4-2cec-4eb4-9ceb-30b723cf22642024-11-18WarningsExact identifier
spl id: 2736a25e-802d-cd18-e063-6394a90a07e7
spl set id: 89ddd2b4-2cec-4eb4-9ceb-30b723cf2264

Reported adverse events (FAERS/openFDA)#

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