NDC | 57337-099-01 |
Set ID | 71c186a1-8283-2482-e053-2995a90acc1f |
Category | HUMAN OTC DRUG LABEL |
Packager | Rejoice International Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- 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.
-
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)