Red Oil Pain Relief Solution
FDA Label NDC 70537-986

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Red Oil Company Inc for the product Red Oil Pain Relief (NDC 70537-986). 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 drug facts, active ingredients, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Camphor 1.19%
Menthol 10.00%
Phenol 0.59%

Purpose

Topical Analgesic

Uses:

For the temporary relief of minor pain, itching, or pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations.

Warnings:

For external use only

Do Not Use

  • on damaged or broken skin.

When Using This Product

  • Avoid contact with the eyes. 
  • Do not bandage tightly.

Stop Use And Ask A Doctor If

  • rash or irritation develops and lasts.
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again with in a few days.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away. 

If Pregnant Or Breast-Feeding,

ask a health professional before use

Directions:

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a  doctor.

Other Information:

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

4-Chloro-5 Methyl-2-(1-Methylethyl) Phenol, Acetone, Mineral Oil (Paraffinum Liquidum), Pinus Palustris Oil, Red 17 (CI 26100)

Questions?

336-478-6734

Package Labeling: 59 Ml

Label (Label)

Label (Label)

Package Labeling: 236 Ml

Label2 (Label2)

Label2 (Label2)

Package Labeling: 473 Ml

Label3 (Label3)

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