Label: THERA WISE NATURAL VAPOR RUB (camphor- natural ointment
- NDC Code(s): 43347-172-01
- Packager: Derma Wise Skin Care Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 19, 2016
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient
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
- use near open flame
- add to hot water or container where heating water
May cause splattering and result in burns.
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
- Inactive ingredients
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 28 g Tube Box
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)