THERA WISE NATURAL VAPOR RUB (camphor- natural ointment

Thera Wise Natural Vapor Rub by

Drug Labeling and Warnings

Thera Wise Natural Vapor Rub by is a Otc medication manufactured, distributed, or labeled by Derma Wise Skin Care Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Camphor Oil 4.8%

Purpose

Cough suppressant

Uses

• Temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
• Alleviates cough to help you get to sleep.

Warnings

For external use only

• Do not take by mouth or place in nostrils.
• Avoid contact with eyes, wounds or damaged skin.
• Wash hands thoroughly after use.

Combustible: Keep away from fire or flames

Do not use this product for persistent chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor

Stop use and consult a doctor if cough:

• persists for more than 1 week
• tends to recur
• is accompanied by fever, rash or persistant headache

A persistent cough may be a sign of a serious condition.

When using this product do not

• heat
• microwave
• use near open flame
• add to hot water or container where heating water

May cause splattering and result in burns.

Keep out of reach of children.

Directions

See warnings under "When using this product".

• For use in adults and children 2 years and older.
• Rub on the throat and chest as a thick layer
• Cover with a warm dry cloth if desired.
• Clothing should be left loose about the throat and chest to help vapours reach the nose and mouth.
• Use up to three times daily or as directed by your doctor.
• For use in children under 2 years of age: please consult a doctor or attending physician

Other information

• Store between 2° and 25° C (35° - 77° F)
• Do not use if seal is broken

Inactive ingredients

Argan Kernel Oil, Bitter Orange Oil, Castor Seed Oil, Eucalyptus Leaf Oil1, Hydrogenated Olive Oil, Olive Fruit Oil, Olive Oil Unsaponifiables, Olive Squalane, , Peppermint Leaf Oil, Pine Needle Oil1, Rhus Verniciflua Peel Wax, Rose Hip Seed Oil1, Sunflower Seed Oil, Thyme Oil.

1 Certified Organic

Questions or Comments?

Call weekdays 9am to 5pm PST @ 1.888.488.1808

PRINCIPAL DISPLAY PANEL - 28 g Tube Box

THÉRA WISE®

Natural Vapor Rub
4.8 % CAMPHOR OIL, OINTMENT

Temporarily relieves cough due to minor throat
and bronchial irritation associated with a cold

WITH EUCALYPTUS LEAF, CAMPHOR BARK,
PINE NEEDLE AND THYME LEAF OIL,
ROSE HIP SEED & ARGAN OIL

NET WT 1OZ (28g)

INGREDIENTS AND APPEARANCE

THERA WISE NATURAL VAPOR RUB 
camphor (natural) ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43347-172
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	1.344 g  in 28 g

Inactive Ingredients
Ingredient Name	Strength
Argan Oil (UNII: 4V59G5UW9X)
Bitter Orange Oil (UNII: 9TLV70SV6I)
Castor Oil (UNII: D5340Y2I9G)
Eucalyptus Oil (UNII: 2R04ONI662)
Hydrogenated Olive Oil (UNII: 53839415GI)
Olive Oil (UNII: 6UYK2W1W1E)
Olea Europaea (Olive) Oil Unsaponifiables (UNII: XO45V955LT)
Squalane (UNII: GW89575KF9)
Mentha Piperita Leaf (UNII: A389O33LX6)
Pine Needle Oil (Pinus Sylvestris) (UNII: 5EXL5H740Y)
Toxicodendron Vernicifluum Fruit Rind Wax (UNII: 6RG2461FCH)
Rosa Moschata Oil (UNII: J99W255AWF)
Sunflower Oil (UNII: 3W1JG795YI)
Thyme Oil (UNII: 2UK410MY6B)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43347-172-01	1 in 1 BOX	08/15/2016
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/15/2016

Labeler - Derma Wise Skin Care Ltd. (242166531)