AMORAY CHEST RUB- camphor (synthetic), eucalyptus oil, and menthol ointment

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Camphor 4.8% Menthol 1.2%, Eucalyptus oil 2.6%, Cough suppressant & Topical Analgesic, Cough suppressant, Cough suppressant & Topical Analgesic
Available from:
MY IMPORTS USA LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- when applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold - when applied to muscles and joints, temporarily relieves minor aches and pains of muscles and joints
Authorization status:
OTC monograph final
Authorization number:
51628-3022-1

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%

Purpos e

Cough suppressant & Topical Analgesic

Cough suppressant

Cough suppressant & Topical Analgesic

Us es

when applied to chest and throat, temporarily relieves cough due to minor throat and bronchial

irritation associated with the common cold

when applied to muscles and joints, temporarily relieves minor aches and pains of muscles and joints

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"

adults and children 2 years and over

rub a thick layer on throat & chest &

cover with a warm, dry cloth if desired

keep clothing loose about throat and chest to help vapors reach the nose and mouth

use up to three times daily or as directed by doctor

for muscle/joint minor aches and pains apply to affected area not more than 3 to 4 times daily

children under 2 years: do not use

Other information

store at room temperature

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

AMORAY CHEST RUB

camphor (synthetic), eucalyptus oil, and menthol ointment

Product Information

MY IMPORTS USA LLC

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:516 28 -30 22

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) -

UNII:5TJD8 2A1ET)

CAMPHOR

(SYNTHETIC)

4.8 g

in 10 0 g

EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2) (EUCALYPTUS OIL - UNII:2R0 4ONI6 6 2)

EUCALYPTUS OIL

2.6 g

in 10 0 g

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

1.2 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

CEDAR LEAF O IL (UNII: BJ16 9 U4NLG)

NUTMEG O IL (UNII: Z1CLM48 9 48 )

THYMO L (UNII: 3J50 XA376 E)

TURPENTINE O IL (UNII: C5H0 QJ6 V7F)

PETRO LATUM (UNII: 4T6 H12BN9 U)

MINERAL O IL (UNII: T5L8 T28 FGP)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:516 28 -30 22-1

113 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 9 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 4/0 9 /20 19

Labeler -

MY IMPORT S USA LLC (195767988)

Revised: 4/2019

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