Label: VAPOREX (camphor- synthetic, eucalyptus oil, and menthol ointment
- NDC Code(s): 24286-1564-2, 24286-1564-3
- Packager: DLC Laboratories, Inc.
- 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 November 29, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
For external use only; avoid contact with eyes.
Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
When using this product, do not
- heat
- microwave
- add to hot water or any container where heating water. May cause splattering and result in burns.
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Directions
See important warnings under "When using this product."
- adults and children 2 years and over:
For cough suppression- rub a thick layer on throat and chest
- cover with a warm, dry cloth if desired
- clothing should be loose about throat and chest to help vapors reach the nose and mouth
- use up to three times daily or as directed by a doctor.
For minor aches and pains of muscles and joints- apply to affected area not more than 3 to 4 times daily
Children under 2 years: do not use
- adults and children 2 years and over:
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 56.7 g Jar Carton
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INGREDIENTS AND APPEARANCE
VAPOREX
camphor (synthetic), eucalyptus oil, and menthol ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24286-1564 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 4.8 g in 100 g EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 1.2 g in 100 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 2.6 g in 100 g Inactive Ingredients Ingredient Name Strength PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) 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:24286-1564-2 1 in 1 CARTON 03/12/2013 11/07/2017 1 62.5 g in 1 JAR; Type 0: Not a Combination Product 2 NDC:24286-1564-3 1 in 1 CARTON 03/12/2013 2 56.7 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 03/12/2013 Labeler - DLC Laboratories, Inc. (093351930) Establishment Name Address ID/FEI Business Operations DLC Laboratories, Inc. 093351930 MANUFACTURE(24286-1564) , LABEL(24286-1564)