Vaporizing Colds Rub (Menthol) Ointment [Delon Laboratories (1990) Ltd] -

VAPORIZING COLDS RUB (MENTHOL) OINTMENT [DELON LABORATORIES (1990) LTD]
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NDC	61734-030-02, 61734-030-03, 61734-030-04, 61734-030-05
Set ID	3ed8bc0c-c229-450b-a491-06b578c1b8ee
Category	HUMAN OTC DRUG LABEL
Packager	Delon Laboratories (1990) Ltd
Generic Name
Product Class
Product Number
Application Number	PART341

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Active ingredients

Camphor 4.7%
Eucalyptus oil 1.2%
Menthol 2.6%
Purpose

Cough suppressant & topical analgesic

Cough suppressant

Cough suppressant & topical analgesic
Uses
temporarily relieves:
- cough due to minor bronchial irritation associated with a cold or inhaled irritants
- cough associated with a cold
- minor aches and pains of muscles and joints
Warnings
Do not use:
- by mouth
- on wounds or damaged skin
- in nostrils
- with tight bandages
Ask a doctor before use if you have
- excessive phlegm (mucus)
- emphysema
- persistent or chronic cough
- asthma
- cough associated with smoking
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 worsen or persist for more than 7 days or clear up and occur again within a few days
- cough perists for more than 1 week, tends to recur, or is accompanied by 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 older:
- rub on the throat and chest in a thick layer
- cover with a warm, dry cloth if desired
- clothing should be loose about throat and chest to help vapors reach the nose and mouth
- use up to three times daily or as directed by a doctor
- children under 2 years of age: ask a doctor
Other information
- store at room temperature
Inactive ingredients

cedar leaf oil, petrolatum, thymol, turpentine
Penetro 1.75g
Delon 4oz (113g)
Delon 3oz (85g)

INGREDIENTS AND APPEARANCE

VAPORIZING COLDS RUB
menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61734-030
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.6 g in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	1.2 g in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4.73 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
CEDAR LEAF OIL (UNII: BJ169U4NLG)
THYMOL (UNII: 3J50XA376E)
TURPENTINE (UNII: XJ6RUH0O4G)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61734-030-04	90 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/24/2011	12/04/2014
2	NDC:61734-030-02	113 g in 1 JAR; Type 0: Not a Combination Product	05/24/2011
3	NDC:61734-030-03	50 g in 1 JAR; Type 0: Not a Combination Product	05/24/2011
4	NDC:61734-030-05	85 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/22/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	05/24/2011

Labeler - Delon Laboratories (1990) Ltd (248364184)

Name	Address	ID/FEI	Business Operations
Establishment
Delon Laboratories (1990) Ltd		243387722	label(61734-030) , manufacture(61734-030) , pack(61734-030)

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Medic

VAPORIZING COLDS RUB (MENTHOL) OINTMENT [DELON LABORATORIES (1990) LTD]

Do not use:

Ask a doctor before use if you have

When using this product, do not

Stop use and ask a doctor if

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