Active Ingredient
Arnica montana 2x HPUS
O24 Pain Neutralizer
FDA Label NDC 58265-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by O24 Naturals, Llc for the product O24 Pain Neutralizer (NDC 58265-007). 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 ingredient, purpose, uses, warnings, otc - do not use, otc - when using, 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
Purpose
Arnica montana 2x HPUS......................Relieves muscle pain & stiffness, swelling from minor injuries, discloloration from bruises.
The letters "HPUS" indicate that the active ingredient in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.
Uses
Temporarily relieves muscle pain and stiffness due to:
- minor injuries
- overexertion
- falls
- pain
- swelling
- discloloration
Reduces symptoms of bruising such as:
Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.
Warnings
For external use only.
Otc - Do Not Use
Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.
Otc - When Using
When using this product
- avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
- use only as directed
- do not tightly wrap or bandage the treated area
- do not apply heat or ice to the treated area immediately before or after use
Otc - Stop Use
Stop use and ask doctor if
- condition persists for more than 3 days or worsens
- symptoms clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, consult 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.
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 physician
Other Information
store in a cool, dry place
Inactive Ingredients
Aloe Barbadensis Leaf juice, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Mentha arvensis Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil
Questions Or Comments
Call 1-866-902-8594 or visit www.024zone.com
Package Label.Principal Display Panel
O24 Naturals
O24 Pain Neutralizer
Homeopathic Topical Temporary Pain Relief
1 fl oz (30 mL)
* Please review the disclaimer below.
