Label: CHESTRUB- camphor (synthetic), menthol and eucalyptus oil ointment
- NDC Code(s): 20276-100-31
- Packager: Delta Brands Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT
Eucalyptus Oil 1.0%
- INDICATIONS & USAGE
Temporarily relieves symptoms associated with the common cold:
- nasal congestion
- chest congestion
Temporarily relieves minor aches and pains of muscles
- DOSAGE & ADMINISTRATION
See important warnings under "Do not Use this product"
- Children under 2 years of age, ask a doctor
- Adults and children 2 years of age and older: rub a thick layer on chest and throat. If desired loosely cover with a soft cloth but keep clothing loose.
- Repeat up to 3 times daily, or as directed by a doctor
Warnings: For external use only. Avoid contact with eyes.Close
- ASK DOCTOR
Ask a doctor before use if you have: Chronic cough that lasts or occurs with smoking, asthma or emphysema.
Cough with excessive phlegm (mucus).Close
- DO NOT USE
Do not use this product; Near an open flame. By adding water. By mouth. In a microwave oven. On wounds or damaged skin. With tight bandages. In nostrils. added to hot water or any container where you are heating water. May cause splattering and result in burns.Close
- STOP USE
Stop use and ask a doctor if: Muscle aches and pains persist for more than 7 days comes back, or occurs with fever, rash or headache that lasts.
These could be signs of a serious condition. If pregnant or breast-feeding consult a physician before use.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.Close
- INACTIVE INGREDIENT
Petrolatum, Nutmeg Oil, Turpentine Oil, Cedar Leaf Oil, Thymol, ParaffinClose
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
camphor menthol eucalyptus oil ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:20276-100 Route of Administration TOPICAL DEA Schedule 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 MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 1 g in 100 g Inactive Ingredients Ingredient Name Strength CEDAR LEAF OIL (UNII: BJ169U4NLG) NUTMEG (UNII: AEE24M3MQ9) PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) THYMOL (UNII: 3J50XA376E) TURPENTINE (UNII: XJ6RUH0O4G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:20276-100-31 113 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/15/2009 Labeler - Delta Brands Inc (102672008) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt Ltd 916837425 manufacture(20276-100) Establishment Name Address ID/FEI Business Operations Ningbo Pulisi Daily Chemical Products Co., Ltd. 529047265 manufacture(20276-100) Establishment Name Address ID/FEI Business Operations Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(20276-100)