O24 ESSENTIAL OIL PAIN RELIEVING- camphor spray

O24 by

Drug Labeling and Warnings

O24 by is a Otc medication manufactured, distributed, or labeled by Revive Bioscience, Inc., Sigan Industries. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

camphor 3.1%

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.

WHEN USING

When using this product

• avoid contact with eyes
  

DO NOT USE

Do not

• apply to wounds or damaged skin
• bandage tightly
  

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
  

PREGNANCY OR BREAST FEEDING

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

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: Spray the affected area with 3-4 sprays up to 4 times per day for maximum relief
• after applying, wait 10 minutes and then wash area if desire 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)

QUESTIONS

Questions or comments?

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

allnaturalpainmanagement.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

O24  ESSENTIAL OIL PAIN RELIEVING
camphor spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76433-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
LEMON OIL (UNII: I9GRO824LL)
ORANGE OIL (UNII: AKN3KSD11B)
PEPPERMINT OIL (UNII: AV092KU4JH)
ROSEMARY OIL (UNII: 8LGU7VM393)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76433-004-30	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/01/2012

Labeler - Revive Bioscience, Inc. (248262920)

Registrant - Revive Bioscience, Inc. (248262920)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries		255106239	manufacture