AMORAY CHEST RUB- camphor (synthetic), eucalyptus oil, and menthol ointment 
MY IMPORTS USA LLC

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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AMORAY ChestRub 51628-3022-1

Drug Facts

Active ingredients

Camphor 4.8%
Menthol 1.2%

Eucalyptus oil 2.6%

Purpose

Cough suppressant & Topical Analgesic

Cough suppressant

Cough suppressant & Topical Analgesic

Uses

Warnings

For external use only; avoid contact with eyes.

Do not use

  • by mouth
  • with tight bandages
  • in nostrils
  • on wounds or damaged skin

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

  • heat
  • microwave
  • 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 and pains persist more than 7 days or come back
  • cough lasts for more than 7 days, comes back, or occurs with fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

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

Directions

see important warnings under " When using this product"

Other information

Inactive ingredients

Petrolatum, Mineral Oil, Nutmeg Oil, Turpentine Oil, Thymol, Cedar Leaf Oil

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY & DRUG FACT PANEL

AMORAY CHEST RUB 
camphor (synthetic), eucalyptus oil, and menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51628-3022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.8 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL2.6 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CEDAR LEAF OIL (UNII: BJ169U4NLG)  
NUTMEG OIL (UNII: Z1CLM48948)  
THYMOL (UNII: 3J50XA376E)  
TURPENTINE OIL (UNII: C5H0QJ6V7F)  
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51628-3022-1113 g in 1 JAR; Type 0: Not a Combination Product04/09/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/09/2019
Labeler - MY IMPORTS USA LLC (195767988)

Revised: 4/2019
Document Id: 87b38f40-3dc3-3590-e053-2a95a90a2793
Set id: 87b38f40-3dc2-3590-e053-2a95a90a2793
Version: 1
Effective Time: 20190429
 
MY IMPORTS USA LLC