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VAPOUR RUB by PROSANA DISTRIBUCIONES, S.A. DE C.V.

Medically reviewed on May 1, 2017

Dosage form: ointment
Ingredients: EUCALYPTUS OIL 1.2g in 100g, CAMPHOR (SYNTHETIC) 4.8g in 100g, MENTHOL 2.6g in 100g
Labeler: PROSANA DISTRIBUCIONES, S.A. DE C.V.
NDC Code: 69728-0030

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

VAPOUR RUB 100g

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)

VAPOUR RUB 
vapor rub ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69728-0030
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTUS OIL (EUCALYPTUS OIL) EUCALYPTUS OIL1.2 g  in 100 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)4.8 g  in 100 g
MENTHOL (MENTHOL) MENTHOL2.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
THYMOL1.2 g  in 100 g
PETROLATUM87.3 g  in 100 g
CEDAR LEAF OIL1.2 g  in 100 g
NUTMEG OIL1.2 g  in 100 g
TURPENTINE OIL0.5 g  in 100 g
Packaging
#Item CodePackage Description
1NDC:69728-0030-21 JAR in 1 BOX
1NDC:69728-0030-1100 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/05/2017
Labeler - PROSANA DISTRIBUCIONES, S.A. DE C.V. (816197867)
Registrant - PROSANA DISTRIBUCIONES, S.A. DE C.V. (816197867)
Establishment
NameAddressID/FEIOperations
PROSANA DISTRIBUCIONES, S.A. DE C.V.816197867manufacture(69728-0030)

 
PROSANA DISTRIBUCIONES, S.A. DE C.V.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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