VAPOUR RUB- vapor rub ointment

VAPOUR RUB by

Drug Labeling and Warnings

VAPOUR RUB by is a Otc medication manufactured, distributed, or labeled by PROSANA DISTRIBUCIONES, S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Camphor 4.8 % Cough Suppresant & Topical Analgesic

Eucalyptus Oil 1.2% Cough Suppresant

Menthol 2.6% Cough Suppresant and Topical Analgesic

Uses

-on 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

Store

Other Information-Store at room temperature

Inactive ingredients

Inactive ingredients

cedarleaf oil, nutmeg oil, spirits of turpentine, thymol

Directions-See important warnings under "When Using This Product"

Directions-See important warnings under "When Using This Product"

For External use only

For external use only; avoid contact with eyes

Do not use

-by mouth

-in nostrils

-on wounds

or damaged skin

-with light bandages

Ask a Doctor

Ask a doctor before use if you have

-cough that occurs with too much phlegm

-persistant or chronic cough, such as occurs with smoking, asthma or emphysema

When using this product

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

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 after a few days

-cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent cough may be a sign of a serious condition

If pregnant

If pregnant or breastfeeding ask a health professional before use

Keep out

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions-see important warnings under "when using this product"

-adults and children 2 years and over

-for cough suppression

-rub a thick layer on throat and chest

-cover with a warm cloth if desired

-keep clothing loose around throat and chest to help vapors reach the nose and mucus

-use up to three times a day or as directed by a doctor

-for muscle/joint aches and pains apply to affected area no more than 3 to 4 times daily

-children under 2 years do not use

If pregnant

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

Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Center

Warning

Failure to follow these warnings could result in serious consequences

For external use only, avoid contact with eyes

Do not use-by mouth-in nostrils-on wounds of damaged skin-with tight bandages

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

-musche aches and pains worsen or persist for more than 7 days or clear up and accur again after a few days

-cough persit for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent cough may be a sign of a serious condition

Principal display 100 g

RESFRIOL

VAPOUR RUB

TOPICAL OINTMENT -MEDICATED

-Nasal Congestion

-Cough Suppresant

NET WT. 3.53 OZ (100g)

INGREDIENTS AND APPEARANCE

VAPOUR RUB 
vapor rub ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69728-0030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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)	4.8 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
THYMOL (UNII: 3J50XA376E)	1.2 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U)	87.3 g  in 100 g
CEDAR LEAF OIL (UNII: BJ169U4NLG)	1.2 g  in 100 g
NUTMEG OIL (UNII: Z1CLM48948)	1.2 g  in 100 g
TURPENTINE OIL (UNII: C5H0QJ6V7F)	0.5 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69728-0030-2	1 in 1 BOX	04/05/2017
1	NDC: 69728-0030-1	100 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/05/2017

Labeler - PROSANA DISTRIBUCIONES, S.A. DE C.V. (816197867)

Registrant - PROSANA DISTRIBUCIONES, S.A. DE C.V. (816197867)

Establishment
Name	Address	ID/FEI	Business Operations
PROSANA DISTRIBUCIONES, S.A. DE C.V.		816197867	manufacture(69728-0030)