Label: VAPORIZING CHEST RUB 4 OZ. 3 PK- camphor, eucalyptus oil, menthol ointment
- NDC Code(s): 57337-099-01
- Packager: Rejoice International Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 September 13, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
Warnings
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)
- cough such as occurs with persistent of chronic smoking, asthma or emphysema
When using this product, do not
- heat
- microwave
- add to hot water or any container where heating water. May cause spattering and result in burns.
Stop use and ask a doctor if
- muscles 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 headche. These could be signs of a serious condition.
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DOSAGE & ADMINISTRATION
Directions
- See important warnings under "When using this product"
- adults and children 2 years and older
For cough suppression
- rub a thick layer on chest & throat
- cover with a warm, dry cloth if desired
- keep clothing loose and throat and chest to help vapors reach the nose and mouth
- use up to 3 times daily or as directed as doctor
- for muscle / joint minor aches and pains apply to affected areas not more than 3 to 4 times daily
- children under 2 years; do not use
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
VAPORIZING CHEST RUB 4 OZ. 3 PK
camphor, eucalyptus oil, menthol ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57337-099 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 4.8 g in 100 mL EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 1.2 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.6 g in 100 mL Inactive Ingredients Ingredient Name Strength CEDAR LEAF OIL (UNII: BJ169U4NLG) NUTMEG OIL (UNII: Z1CLM48948) PETROLATUM (UNII: 4T6H12BN9U) THYMOL (UNII: 3J50XA376E) TURPENTINE OIL (UNII: C5H0QJ6V7F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57337-099-01 3 in 1 BOX 07/24/2018 1 113 mL 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 not final part348 07/20/2018 Labeler - Rejoice International Inc. (078741245) Establishment Name Address ID/FEI Business Operations China Ningbo Shangge Technology Co., Ltd. 529287434 manufacture(57337-099)
