ASSURED VAPORIZING CHEST RUB- camphor and eucalyptus oil and menthol ointment

Assured Vaporizing Chest Rub by

Drug Labeling and Warnings

Assured Vaporizing Chest Rub by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc., Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Camphor            4.7%

Menthol             1.25%

Eucalyptus Oil     1.2%

PURPOSE

Purpose

Cough suppressant/topical analgesic

Cough suppressant/topical analgesic

Cough suppressant

INDICATIONS & USAGE

Uses

Temporarily relieves throat and chest

• cough
• nasal congestion due to common cold
• aching muscles
• minor aches and pains

WARNINGS

Warnings

For external use only. Avoid contact with eyes.

DO NOT USE

Do not use

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

ASK DOCTOR

Ask a doctor before use if you have

• asthama
• excessive phlegm (mucus)
• emphysema
• persistent or chronic cough
• cough associated with smoking

WHEN USING

When using this product do not

• heat
• microwave
• use near open flame
• add to hot water or any container where heating water may cause splattering and result in burns

STOP USE

Stop use and ask a doctor if

• muscle aches/pain persist more than 7 days or come back
• cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious conditions.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Centre right away.

DOSAGE & ADMINISTRATION

Directions

• see important warnings under "When using this product"
• children under 2 years of age, ask a doctor before using this product
• adults and children 2 years and older, rub a thick layer on chest and throat or rub on sore aching muscles. If desired, cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily.

SPL UNCLASSIFIED SECTION

Other information

• Store at room temperature

INACTIVE INGREDIENT

Inactive ingredients

cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ASSURED VAPORIZING CHEST RUB

INGREDIENTS AND APPEARANCE

ASSURED VAPORIZING CHEST RUB 
camphor and eucalyptus oil and menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-7991
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4.7 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	1.2 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CEDAR LEAF OIL (UNII: BJ169U4NLG)
NUTMEG OIL (UNII: Z1CLM48948)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
THYMOL (UNII: 3J50XA376E)
TURPENTINE OIL (UNII: C5H0QJ6V7F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-7991-4	113 g in 1 JAR; Type 0: Not a Combination Product	06/26/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/26/2018

Labeler - Greenbrier International, Inc. (610322518)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(33992-7991)