Label: MEDICATED CHEST- camphor, eucalyptus oil, menthol jelly
- NDC Code(s): 62011-0075-1
- Packager: Strategic Sourcing Services LLC
- 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.
Updated April 20, 2022
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- Active ingredients
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 emphusema
When using this product do not
- add to hot water or any container when heating water. May cause splattering and result in burns.
Stop use and ask a doctor if
- muscle aches and pains persist more than 7 days or come back
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of serious condition.
See important warnings under "When using this product"
- adults + children 2 yrs + over:
- rub a thick layer on chest + throat or rub on sore aching muscles
- 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 per 24 hours or as directed
- children under 2 years of age: ask a doctor
- Other information
- Inactive ingredients
- Adverse Reactions
- principal display panel
INGREDIENTS AND APPEARANCE
camphor, eucalyptus oil, menthol jelly
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0075 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 48 mg in 1 g EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 12 mg in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 26 mg in 1 g Inactive Ingredients Ingredient Name Strength CEDAR LEAF OIL (UNII: BJ169U4NLG) NUTMEG OIL (UNII: Z1CLM48948) TURPENTINE OIL (UNII: C5H0QJ6V7F) THYMOL (UNII: 3J50XA376E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62011-0075-1 1 in 1 PACKAGE 02/02/2012 1 100 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 02/02/2012 Labeler - Strategic Sourcing Services LLC (116956644) Registrant - Vi-Jon, LLC (088520668) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(62011-0075)