ASTONEA CHEST RUB- camphor (synthetic), eucalyptus oil, and menthol ointment
ASTONEA LABS PRIVATE LIMITED

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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ASTONEA ChestRub

Drug Facts

Active ingredients

Camphor 4.7%

Menthol 1.25%

Eucalyptus oil 1.2%

Purpose

Cough suppressant & Topical Analgesic

Cough suppressant

Cough suppressant & Topical Analgesic

Uses

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

cedar leaf oil, methylparaben, nutmeg oil, petrolatum, propylparaben, thymol, turpentine oil

PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact Panel

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77338-321
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.047 g in 1 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	0.012 g in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.0125 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CEDAR LEAF OIL (UNII: BJ169U4NLG)
NUTMEG OIL (UNII: Z1CLM48948)
THYMOL (UNII: 3J50XA376E)
TURPENTINE OIL (UNII: C5H0QJ6V7F)
PETROLATUM (UNII: 4T6H12BN9U)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77338-321-21	113 g in 1 JAR; Type 0: Not a Combination Product	04/08/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	04/05/2019

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 9/2022

Document Id: e81a4c38-108e-1f15-e053-2995a90aedc1

Set id: e81a4c38-108d-1f15-e053-2995a90aedc1

Version: 1

Effective Time: 20220907

ASTONEA LABS PRIVATE LIMITED