Label: MEDICATED CHEST RUB (camphor- synthetic, eucalyptus oil, and menthol, unspecified form ointment
- NDC Code(s): 50804-078-01
- Packager: GOODSENSE
- 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 February 16, 2021
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
- do not microwave
- do not 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"
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Adults and children 2 years old and older:
- rub a thick layer on chest & throat for cough, or rub on sore aching muscles or joints
- cover with a warm, dry cloth if desired
- keep clothing loose about throat/chest to help vapors reach the nose/mouth
- repeat up to three times daily or as directed by a doctor
- Children under 2 years: do not use
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Adults and children 2 years old and older:
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 g Jar Label
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INGREDIENTS AND APPEARANCE
MEDICATED CHEST RUB
camphor (synthetic), eucalyptus oil, and menthol, unspecified form ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-078 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.048 g in 1 g EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 0.012 g in 1 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 0.026 g in 1 g Inactive Ingredients Ingredient Name Strength CEDAR LEAF OIL (UNII: BJ169U4NLG) NUTMEG OIL (UNII: Z1CLM48948) TURPENTINE OIL (UNII: C5H0QJ6V7F) THYMOL (UNII: 3J50XA376E) WHITE PETROLATUM (UNII: B6E5W8RQJ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50804-078-01 100 g in 1 JAR; Type 0: Not a Combination Product 02/11/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/11/2021 Labeler - GOODSENSE (076059836) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(50804-078)