VAPORIZING CHEST RUB 4 OZ. 3 PK- camphor, eucalyptus oil, menthol ointment 
Rejoice International Inc.

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.

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Vaporizing Chest Rub 4 oz 3 pk

Active ingredients

Camphor, 4.8%

Eucalyptus Oil, 1.2%

Menthol, 2.6%

Purpose

Cough suppressant & topical analgesic

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Warnings

For external use only; avoid contact with eyes

Do not use

Ask a doctor before use if you have

When using this product, do not

Stop use and ask a doctor if

Directions

For cough suppression

Inactive ingredients

Cedarleaf Oil, Nutmeg Oil, Petrolatum, Thymol, Turpentine Oil

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label

VAPORIZING CHEST RUB 4 OZ.  3 PK
camphor, eucalyptus oil, menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-099
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 OIL1.2 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CEDAR LEAF OIL (UNII: BJ169U4NLG)  
NUTMEG OIL (UNII: Z1CLM48948)  
PETROLATUM (UNII: 4T6H12BN9U)  
THYMOL (UNII: 3J50XA376E)  
TURPENTINE OIL (UNII: C5H0QJ6V7F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57337-099-013 in 1 BOX07/24/2018
1113 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/20/2018
Labeler - Rejoice International Inc. (078741245)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Technology Co., Ltd.529287434manufacture(57337-099)

Revised: 9/2019
Document Id: 9273bf56-27b8-0971-e053-2995a90ac683
Set id: 71c186a1-8283-2482-e053-2995a90acc1f
Version: 2
Effective Time: 20190913
 
Rejoice International Inc.