Label: CHEST RUB- menthol, camphor, eucalyptus oil ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 69859-001-38 - Packager: JT Cosmetics and Chemicals
- 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.
Drug Label Information
Updated June 1, 2015
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- Drug Facts
- Active Ingredients
- Purpose
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- INDICATIONS & USAGE
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WARNINGS
Warnings: For external use only. Not for internal use. Avoid contact with eyes. Do not put in mouth, nostrils or on wounds or damaged skin.
If pregnant or breast feeding: Consult a physician before use. Do not use near open flame, in a microwave oven or in a container in which water is being heated except when adding to cold water in a hot steam vaporizer.
Consult a physician before use: If you have asthma, emphysema, persistent or chronic cough, cough associated with smoking or excessive mucus. If muscle aches persist more than 7 days or comes back or if cough lasts more than 7 days, comes back or occurs with fever, rash or a persistent headache.
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DOSAGE & ADMINISTRATION
Directions: Adults and children 2 years of age and older rub a thick layer on chest and throat for temporary relief from nasal congestion and coughing due to colds or rub on sore, aching muscles. If desired, loosely cover with a soft dry cloth but keep clothing loose. Repeat up to three times daily, especially at bedtime. Children under 2 years of age, consult your physician.
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INGREDIENTS AND APPEARANCE
CHEST RUB
menthol, camphor, eucalyptus oil ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69859-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1 g in 100 g CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 4.7 g in 100 g EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 1 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) MINERAL OIL (UNII: T5L8T28FGP) NUTMEG OIL (UNII: Z1CLM48948) TURPENTINE OIL (UNII: C5H0QJ6V7F) THYMOL (UNII: 3J50XA376E) CEDAR LEAF OIL (UNII: BJ169U4NLG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69859-001-38 113 g in 1 JAR; 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 05/23/2015 Labeler - JT Cosmetics and Chemicals (650884849) Establishment Name Address ID/FEI Business Operations JT Cosmetics and Chemicals 650884849 manufacture(69859-001)
