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

Astonea Chest Rub by

Drug Labeling and Warnings

Astonea Chest Rub by is a Otc medication manufactured, distributed, or labeled by ASTONEA LABS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/05/2019

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)