![VAPORIZING CHEST RUB COUGH SUPRESSANT (CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL) OINTMENT [FILO AMERICA]](https://medic.hrt.org//dailymed/images/c34324da-9ee5-4fe9-be04-ef8a67218f2a/menthol ChestRub 4oz.jpg)
| NDC | 50438-502-01 |
| Set ID | c34324da-9ee5-4fe9-be04-ef8a67218f2a |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Filo America |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
-
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
- do not microwave
- do not add to hot water or any container where heating water. May cause splattering and result in burns.
- do not take by mouth or place in nostrils
-
Directions
- see important warnings under "When using this product"
- adults and children 2 year and over.
for cough suppression
- rub a thick layer on the throat and chest
- cover with a warm, dry cloth if desired
- keep clothing loose about throat and chest to help vapors reach the nose and mouth
- use up to 3 times daily, or as directed by a doctor
for muscle/joint minor aches and pains apply
- to affected area not more than 3-4 times daily
- children under 2 yeas : ask a doctor
other information
- store at room temperature
if pregnant or breast feeding
- ask a health professional before use
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 100g Jar Label
-
INGREDIENTS AND APPEARANCE
VAPORIZING CHEST RUB COUGH SUPRESSANT
camphor (synthetic), eucalyptus oil, and menthol ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50438-502 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic) 4.7 g in 100 g Eucalyptus Oil (UNII: 2R04ONI662) (Eucalyptus Oil - UNII:2R04ONI662) Eucalyptus Oil 1 g in 100 g Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 1 g in 100 g Inactive Ingredients Ingredient Name Strength Nutmeg Oil (UNII: Z1CLM48948) 0.6 g in 100 g TURPENTINE OIL (UNII: C5H0QJ6V7F) Petrolatum (UNII: 4T6H12BN9U) propylparaben (UNII: Z8IX2SC1OH) THYMOL (UNII: 3J50XA376E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50438-502-01 113 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 05/05/2015 Labeler - Filo America (943873703) Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265) Establishment Name Address ID/FEI Business Operations Ningbo Pulisi Daily Chemical Products Co., Ltd. 529047265 manufacture(50438-502)
