O24 PAIN NEUTRALIZER- arnica montana liquid O24 PAIN NEUTRALIZER- arnica montana spray

O24 Pain Neutralizer by

Drug Labeling and Warnings

O24 Pain Neutralizer by is a Homeopathic medication manufactured, distributed, or labeled by O24 Naturals, LLC, D&D Essential Oils, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Arnica montana 2x HPUS

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

Reduces symptoms of bruising such as:

• pain
• swelling
• discloloration

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.

Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.

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

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

If pregnant or breastfeeding, consult a health professional before use.

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

PRINCIPAL DISPLAY PANEL

O24 Naturals

O24 Pain Neutralizer

Homeopathic Topical Temporary Pain Relief

1 fl oz (30 mL)

INGREDIENTS AND APPEARANCE

O24 PAIN NEUTRALIZER 
arnica montana liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58265-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	2 [hp_X]  in 9.4 g

Inactive Ingredients
Ingredient Name	Strength
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ROSEMARY OIL (UNII: 8LGU7VM393)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58265-007-94	9.4 g in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/17/2023

O24 PAIN NEUTRALIZER 
arnica montana spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58265-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	2 [hp_X]  in 30 g

Inactive Ingredients
Ingredient Name	Strength
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ROSEMARY OIL (UNII: 8LGU7VM393)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58265-006-30	1 in 1 CARTON	01/17/2023
1		30 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/17/2023

Labeler - O24 Naturals, LLC (962526559)

Establishment
Name	Address	ID/FEI	Business Operations
D&D Essential Oils, LLC		051894458	manufacture(58265-006, 58265-007)