Label: CAREALL MEDICATED CHEST RUB- camphor, menthol, eucalyptus ointment
- NDC Code(s): 51824-045-03, 51824-045-04
- Packager: New World Imports, 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.
Updated November 1, 2021
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
For external use only. Avoid contact with eyes.
Do not use
- by mouth
- in nostrils
- on wounds or damaged skin
- with tight bandages
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
- add to hot water or any container where heating water. May cause splattering and result in burns
Stop use and ask a doctor if
- muscle aches/pain persist more than 7 days or come back
- cough lasts 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, ask a health professional before use
DOSAGE & ADMINISTRATION
See important warnings under "When using this product"
- Children under 2 years of age, do not use.
- Adults and children 2 years and older, rub a thick layer on chest and throat or rub on sore aching muscles. If desired cover with a dry soft cloth but keep clothing loose around throat/chest to help vapors reach the nose/mouth. Repeat up to 3 times per 24 hours or as directed by a doctor.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
CAREALL MEDICATED CHEST RUB
camphor, menthol, eucalyptus ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-045 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 MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL .026 g in 1 g EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 0.012 g in 1 g Inactive Ingredients Ingredient Name Strength CEDAR LEAF OIL (UNII: BJ169U4NLG) NUTMEG OIL (UNII: Z1CLM48948) PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) THYMOL (UNII: 3J50XA376E) TURPENTINE OIL (UNII: C5H0QJ6V7F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-045-03 100 g in 1 JAR; Type 0: Not a Combination Product 07/09/2014 2 NDC:51824-045-04 113 g in 1 JAR; Type 0: Not a Combination Product 07/09/2014 07/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/09/2014 Labeler - New World Imports, Inc (075372276)