Ramedica Roll On
FDA Label NDC 66059-0003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ramedicare Sdn. Bhd. for the product Ramedica Roll On (NDC 66059-0003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Camphor  10.8%

Wintergreen Oil (Methyl Salicylate) 0.2%

Eucalyptus Oil   7%

Menthol   11%

Purpose

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

Uses

Temporarily relieves minor aches & pains related to

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

Warnings

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

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

Other Information

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

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

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