O24
FDA Label NDC 76433-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Revive Bioscience, Inc. for the product O24 (NDC 76433-005). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - do not use, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

camphor 3.1%

Otc - Purpose

Topical Analgesic

Indications & Usage

For the temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains, bruises and sprains.

Warnings

For external use only.

Otc - When Using

When using this product

  • avoid contact with eyes

Otc - Do Not Use

Do not

  • apply to wounds or damaged skin
  • bandage tightly

Otc - Stop Use

Stop use and ask a doctor if

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

Otc - Pregnancy Or Breast Feeding

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


Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directions

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, massaging area gently
  • wash hands after application
  • after applying, wait 10 minutes and then wash area if desired to remove scent.  This will not decrease effectiveness.
  • children under 2 years of age: consult a physician

Storage And Handling

store in a cool, dry place

Inactive Ingredient

Aloe Vera Oil, Eucalyptus Globulus Leaf Oil, Lemon Peel Oil (Citrus Medica Limonum), Orange Oil (Citrus Aurantium Dulcis), Peppermint Oil (Mentha Piperita), Rosemary Leaf Oil (Rosmarinus Officinalis)

Otc - Questions

Questions or comments?

1.877.310.4173 9:00am-5:00pm EST M-F

allnaturalpainmanagement.com

Package Label.Principal Display Panel

O24 Towelette Label (O24label)

O24 Towelette Label (O24label)

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