Otc - Active Ingredient
Camphor 3.1%
O24 Pain Neutralizer
FDA Label NDC 72608-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by D&d Essential Oils, Llc., for the product O24 Pain Neutralizer (NDC 72608-004). 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 - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Camphor 3.1%.............................External Analgesic
Indications & Usage
temporarily relieves minor aches and pains of muscles and joints associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
For External Use Only.
Otc - Do Not Use
Do Not Use
- For arthritis-like conditions in children under 2.
- on wounds, damaged, broken or irritated skin.
Otc - When Using
When Using This Product
- use only as directed.
- do not bandage tightly.
- avoid contact with the eyes and mucous membranes.
Otc - Stop Use
Stop Use and Ask Doctor If
- condition worsens
- symptoms last more than 7 days
- symptoms clear up and come back in a few days
Otc - Keep Out Of Reach Of Children
Keep our of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Dosage & Administration
- adults and children 2 years of age and older: apply to (gently wipe) affected area not more than 3 to 4 times daily
- children under 2 years of age: consult a physician
Inactive Ingredient
Aloe Barbadensis Leaf Juice, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Mentha arvensis (Peppermint Leaf) Oil, Rosmarinus Ofcinalis Leaf (Rosemary) Oil
Description
Distributed by
O24 TM Naturals, LLC
306 Hallmark Dr.,
Arlington, TX 76011
Questions?
Call TOLL-FREE:
1.866.902.8594 or visit us at:
www.O24zone.com
O24 TM is a Registered Trademark
of O24 TM Naturals, LLC.
Package Label.Principal Display Panel
024 TMNaturals
024 TM
Pain Neutralizer
Topical Analgesic
Penetrating Pain Relief
for the temporary relieft of minor aches & pains associated with arthritis, strains, backaches, and bruises
10 Towelettes
(4 in x 6 in / 10.2 cm x 15.2 cm)
O24towelettes (O24towelettes)
* Please review the disclaimer below.
