Label: VICKS VAPORUB- camphor, eucalyptus oil, and menthol oilment ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 69772-390-01, 69772-390-02, 69772-390-03 - Packager: Genesis Imports & Exports
- 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 December 28, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
- WARNINGS
- ASK DOCTOR
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions:
See important warnings under when using this product
- adults and children 2 years and over:
- RUB A THICK LAYER ON CHEST & THROAT OR RUB ON SORE ACHING MISCLES
- Cover with a warm, dry cloth if desired
- Keep clothing loose abouth throat/chest to help vapors reach the nose/ mouse
- repeat up three times per 24 hours or as directed by doctor
- children under 2 yearsL do not use.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VICKS VAPORUB
camphor, eucalyptus oil, and menthol oilment ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69772-390 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 0.012 g in 1 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.048 g in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.026 g in 1 g Inactive Ingredients Ingredient Name Strength CEDAR LEAF OIL (UNII: BJ169U4NLG) NUTMEG OIL (UNII: Z1CLM48948) THYMOL (UNII: 3J50XA376E) TURPENTINE OIL (UNII: C5H0QJ6V7F) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69772-390-01 100 g in 1 JAR; Type 0: Not a Combination Product 11/24/2016 2 NDC:69772-390-02 50 g in 1 JAR; Type 0: Not a Combination Product 11/24/2016 3 NDC:69772-390-03 12 g in 1 JAR; Type 0: Not a Combination Product 11/24/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/24/2016 Labeler - Genesis Imports & Exports (078760958) Registrant - Teresa Cecena (078760958) Establishment Name Address ID/FEI Business Operations Genesis Imports & Exports LLC 078760958 relabel(69772-390) Establishment Name Address ID/FEI Business Operations procter & Gamble Manufactura S De RL De CV 812807550 manufacture(69772-390) Establishment Name Address ID/FEI Business Operations Roir SA de CV 812825434 relabel(69772-390)