FDA.reportPublic FDA data

VAPOUR RUB

Manufacturer
PROSANA DISTRIBUCIONES, S.A. DE C.V.
Effective date
2017-04-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:43

Label at a glance#

ProductVAPOUR RUB
Active ingredientEUCALYPTUS OIL, CAMPHOR (SYNTHETIC), MENTHOL
Label structure10 sections

Indications and 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

Dosage and administration

Directions-See important warnings under "When Using This Product" 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 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 do not: -heat-microwave-add to hot water or...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

-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 SAFETY INFORMATION

Other Information-Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

cedarleaf oil, nutmeg oil, spirits of turpentine, thymol

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

WARNINGS SECTION

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

For External use only

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

GENERAL PRECAUTIONS SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding ask a health professional before use

Keep out

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Warning

INDICATIONS & USAGE SECTION

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 PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RESFRIOL VAPOUR RUB

Topical Ointment

MEDICADO/ MEDICADO

Nasal Congestion

-Cough Suppresant

NET WT 1.76 OZ (50g)

boxbox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
727137camphor 4.8 % / eucalyptus oil 1.2 % / menthol 2.6 % Topical OintmentPSN1
727137camphor 0.048 MG/MG / Eucalyptus oil 0.012 MG/MG / menthol 0.026 MG/MG Topical OintmentSCD1
727137camphor 4.8 % / eucalyptus oil 1.2 % / menthol 2.6 % Chest RubSY1
727137camphor 4.8 % / eucalyptus oil 1.2 % / menthol 2.6 % Topical OintmentSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69728-0020-22020-01-31C16284748780-19d75b9cf-d358-f424-e053-dadaa90a57ceVAPOUR RUB 50g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69728-0020-1VAPOUR RUB50 g in 1 JAROINTMENT501
69728-0020-2VAPOUR RUB1 in 1 BOXOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69728-0020VAPOUR RUB (VAPOR RUB) OINTMENT [PROSANA DISTRIBUCIONES, S.A. DE C.V.]1Legacy NDC, 2 package rows20170501_4c6e475a-5a5d-1ed4-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69728-002069728-0020-1, 69728-0020-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS OIL2R04ONI662ACTIB
THYMOL3J50XA376EIACT
PETROLATUM4T6H12BN9UIACT
CEDAR LEAF OILBJ169U4NLGIACT
NUTMEG OILZ1CLM48948IACT
TURPENTINE OILC5H0QJ6V7FIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4c6e475a-5a5e-1ed4-e054-00144ff8d46c4c6e475a-5a5d-1ed4-e054-00144ff8d46c2017-04-05WarningsExact identifier
spl id: 4c6e475a-5a5e-1ed4-e054-00144ff8d46c
spl set id: 4c6e475a-5a5d-1ed4-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.