VAPOUR RUB (VAPOR RUB) OINTMENT [PROSANA DISTRIBUCIONES, S.A. DE C.V.]

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VAPOUR RUB (VAPOR RUB) OINTMENT [PROSANA DISTRIBUCIONES, S.A. DE C.V.]
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NDC 69728-0020-1, 69728-0020-2
Set ID 4c6e475a-5a5d-1ed4-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager PROSANA DISTRIBUCIONES, S.A. DE C.V.
Generic Name
Product Class
Product Number
Application Number PART341
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  • 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 PANEL

    RESFRIOL VAPOUR RUB

    Topical Ointment

    MEDICADO/ MEDICADO

    Nasal Congestion

    -Cough Suppresant

    NET WT 1.76 OZ (50g)

    box

  • INGREDIENTS AND APPEARANCE
    VAPOUR RUB 
    vapor rub ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69728-0020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL0.6 g  in 50 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)2.4 g  in 50 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.3 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    THYMOL (UNII: 3J50XA376E) 0.6 g  in 50 g
    PETROLATUM (UNII: 4T6H12BN9U) 43.65 g  in 50 g
    CEDAR LEAF OIL (UNII: BJ169U4NLG) 0.6 g  in 50 g
    NUTMEG OIL (UNII: Z1CLM48948) 0.6 g  in 50 g
    TURPENTINE OIL (UNII: C5H0QJ6V7F) 0.25 g  in 50 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69728-0020-21 in 1 BOX04/05/2017
    1NDC:69728-0020-150 g in 1 JAR; Type 0: Not a Combination Product
    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/FEIBusiness Operations
    PROSANA DISTRIBUCIONES, S.A. DE C.V.816197867manufacture(69728-0020)
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