Country: United States
Language: English
Source: NLM (National Library of Medicine)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET), EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Greenbrier International, Inc.
TOPICAL
OTC DRUG
Purpose Cough Suppressant & Topical analgesic Cough Suppressant Cough Suppressant & Topical analgesic Uses - use on chest and throat to temporarily relieve cough - use on aching muscles to temporarily relieve minor aches and pains
OTC monograph final
ASSURED VAPORIZING CHEST RUB- CAMPHOR AND EUCALYPTUS OIL AND MENTHOL OINTMENT GREENBRIER INTERNATIONAL, INC. _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._ ---------- ACTIVE INGREDIENTS Camphor 4.7% Eucalyptus Oil 1.2% Menthol 1.25% PURPOS E Cough Suppressant & Topical analgesic Cough Suppressant Cough Suppressant & Topical analgesic US ES use on chest and throat to temporarily relieve cough use on aching muscles to temporarily relieve minor aches and pains WARNINGS For external use only; Do not take by mouth or place in nostrils. Avoid excessive heat. Never expose this product to flame or place in any container in which you are heating water. Never place in microwave oven. CONSULT A DOCTOR AND DISCONTINUE USE; If cough persist for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache. KEEP OUT OF REACH OF CHILDREN In case of accidental ingestion, seek professional assistance or contact a Poison Control Centre immediately. DIRECTIONS : Adults and children over 2 years of age; Rub a thick layer on chest and throat to provide temporary relief from nasal congestion and coughing due to colds. If desired, cover with dry, warm cloth, but keep clothing loose to let the vapours rise to nose and mouth. Repeat up to three times daily, especially at bedtime, or as directed by a doctor. Children under two years of age, consult a doctor. INACTIVE INGREDIENTS: Petrolatum, Mineral Oil, Nutmeg Oil, Spirits of Turpentine, Cedarleaf Oil, Thymol PRINCIPAL DISPLAY PANEL ASSURED VAPORIZING CHEST RUB ASSURED VAPORIZING CHEST RUB camphor and eucalyptus oil and menthol ointment PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:339 9 2-79 9 2 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJ Read the complete document