VAPORIZING CHEST RUB- menthol and camphor and eucalyptus oil gel

Vaporizing Chest Rub by

Drug Labeling and Warnings

Vaporizing Chest Rub by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC, Anicare Pharmaceuticals Pvt. Ltd, Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Camphor            4.7%

Menthol             1.0%

Eucalyptus Oil   1.0%

PURPOSE

Purpose

Decongestant

INDICATIONS & USAGE

Uses

• on chest and throat, helps temporarily relive cough due to common cold.
• on joints and muscles, temporarily relives minor aches and pains.

WARNINGS

Warnings

For external use only; avoid contact with eyes.

DO NOT USE

Do not use

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

ASK DOCTOR

Ask doctor before use if you have,

• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with asthma, emphysema, or smoking

WHEN USING

When using this product, do not

• heat
• microwave
• add to hot water or any container where heating water. May cause splattering and results in burns

STOP USE

Stop use and ask a doctor if

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

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children

If ingested get medical help or contact a Poison control center immediately

DOSAGE & ADMINISTRATION

Directions

• adults and children 2 years and over
• rub a thick layer on chest and throat or rub on sore aching muscles

• keep clothing loose around chest/throat to help vapors reach the nose/mouth

• repeat up to 3 times per 24 hours or as directed by doctor
• do not use on children under 2 years unless directed by doctor

INACTIVE INGREDIENT

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

VAPORISING CHEST RUB
NASAL DECONGESTANT AND COUGH SUPPRESSANT
NET WT.4 OZ (113g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VAPORIZING CHEST RUB 
menthol and camphor and eucalyptus oil gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-012
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
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	1 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: 52000-012-08	50 g in 1 BOTTLE, PLASTIC
2	NDC: 52000-012-09	56.6 g in 1 BOTTLE, PLASTIC
3	NDC: 52000-012-10	100 g in 1 BOTTLE, PLASTIC
4	NDC: 52000-012-11	113 g in 1 BOTTLE, PLASTIC
5	NDC: 52000-012-12	150 g in 1 BOTTLE, PLASTIC
6	NDC: 52000-012-13	170 g in 1 BOTTLE, PLASTIC
7	NDC: 52000-012-14	226 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/15/2013

Labeler - Universal Distribution Center LLC (019180459)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(52000-012)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(52000-012)