Canada - Prestige Brands

2010/02/05 3:04:40 PM
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Health
Canada
12/13
Sante
Canada
Product Licence
Licence de mise en marché
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Product NumberlNuméro deproduit: 80015664
Brand NamelMarque nominative: Chioraseptic® Max Sore Throat
Issued tolEmise a:
Name of IicenseelNom du titulaire:
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Medtech Products, Inc.
90 North Broadway
lrvington, New York, 10533
U.S.A.
Authorized for the followlng/Autorisé pour ce qui suit:
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Dosage formlForme posologique: Lozenge
Recommended route of administrationNole d’administration recommandée:
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Buccal
Recommended doselDose recommandée:
Take one lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the
Adults:
mouth.
Children :
(6 years and older): Take one lozenge every 2 hours as needed. Allow lozenges to dissolve
slowly in the mouth.
Children:
(under 6 years of age): Consult a doctor.
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p
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Recommended duration of uselDurée d’utllisatlon recommandée:
N/A
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Recommended use or purpose/Usage ou les fins recommandés:
Oral Anesthetic/Analgesic Lozenges. Temporarily relieves sore throat, Temporarily relieves: Pain of sore throat, coughs. Helps
ease/relieve nasal congestion, makes nasal passages feel clearer.
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Risk informationlRenseignements surles risques:
Cautions and Warnings
Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine,
benzocaine or other “caine’ anesthetics. Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied
by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. If symptoms are severe or persist
for more than 2 days consult a doctor. If cough worsens, persists for more than 7 days, or is accompanied by a high fever
consult a doctor. When using this product: do not exceed recommended dosage. Stop use and ask a doctor if: irritation, pain
or redness persists or worsens, swelling, rash or fever develops. If pregnant or breast-feeding: ask a health care practitioner
before use. Keep out of reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison
Control Centre right away.
Medicinal Ingredientsllngrédients médicinaux:
I
Proper Name
Nom propre
Common Name
Nom usuel
Quantity per
Dosage Unit
Quantité par unite
posologique
Benzocaine
Benzocaine
15 mg
N/A
N/A
Synthetic
Menthol
Menthol
10 mg
N/A
N/A
Mentha arvensis, leaves
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Extract
Extrait
Potency
Activité
Source Materiai
Matière d’origine
Page 1 of 2
Canada
U!U/UX/U5 t1:U5:42 PM
•
Health
Canada
I
Sante
Canada
I
Product Number/Numéro deprocluit: 80015664
Brand NamelMarque nominative: Chloraseptic® Max Sore Throat
This licence is issued by the Minister of Health under the authority of section 7 of the Natural Health Products Regulations. Sale of
the described natural health product, including any changes thereto pursuant to section 11 of the Regulations, is subject to the
Food and Drugs Act and to the Natural Health Products Regulations.
Cette licence est émise par/a ministre de Ia Sante en vertu de l’article 7 du Règlement sur les produits do sante nature/s.
La vente du produit do sante naturei décrit dans Ia presente, y compris toute modification afférente au sons de l’article 11 du
RegIemen est assujettie a Ia Lol sur les ailments et drogues et au Règiement sur los produits de sante naturels.
lssued/émis let 2010-02-03
Revised/Amended/Modifié le: N/A
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If,
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Director GenerallDirectrice générale
N H PDIDPSN
Page2of2
Canad I
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Product Licence
Licence de mise en marché
Product Number/Numéro de produit: 80032643
Brand Name/Marque nominative: Cloraseptic Warming - Honey Lemon
Other Brand Name(s)/Autre(s) marque(s) nominative(s):
Cloraseptic Warming Sore Throat - Honey Lemon with real Honey
Issued to/Émise à:
Name of licensee/Nom du titulaire:
Prestige Brands Inc.
90 N. Broadway
Irvington, New York, 10533
U.S.A.
Authorized for the following/Autorisé pour ce qui suit:
Dosage form/Forme posologique: Lozenge
Recommended route of administration/Voie d'administration recommandée:
Oral
Recommended dose/Dose recommandée:
Adults :
Take 1 lozenge every 2 hours as needed up to a maximum of 12 times per day. Allow
lozenge to dissolve slowly in mouth.
Recommended duration of use/Durée d'utilisation recommandée:
N/A
Recommended use or purpose/Usage ou les fins recommandés:
Oral Anesthetic/Analgesic Lozenges. For the temporary relieve of sore throat. For the temporary relief of pain of sore throat.
Risk Information/Renseignements sur les risques:
Cautions and Warnings
Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine,
benzocaine or other “caine” anesthetics. If symptoms are severe or persist for more than 2 days consult a doctor. Keep out
of reach of children. Children under the age of 3 consult a doctor before use.
Medicinal Ingredients/Ingrédients médicinaux:
Proper Name
Nom propre
Common Name
Nom usuel
Quantity per
Dosage Unit
Quantité par unité
posologique
Extract
Extrait
Potency
Activité
Source Material
Matière d'origine
4-Aminobenzoic
acid, ethyl ester
Benzocaine
15 mg
N/A
N/A
Benzocaine (Synthetic)
This licence is issued by the Minister of Health under the authority of section 7 of the Natural Health Products Regulations. Sale of
the described natural health product, including any changes thereto pursuant to section 11 of the Regulations, is subject to the
Food and Drugs Act and to the Natural Health Products Regulations.
Cette licence est émise par la ministre de la Santé en vertu de l’article 7 du Règlement sur les produits de santé naturels.
La vente du produit de santé naturel décrit dans la présente, y compris toute modification afférente au sens de l’article 11 du
Règlement, est assujettie à la Loi sur les aliments et drogues et au Règlement sur les produits de santé naturels.
Issued/émis le: 2012-06-07
Revised/Amended/Modifié le: N/A
Page 1 of 2
Product Number/Numéro de produit: 80032643
Brand Name/Marque nominative: Cloraseptic Warming - Honey Lemon
Director General/Directeur général
NHPD/DPSN
Page 2 of 2
2010/02/05 2:58:00 P11
Health
Canada
4/13
Sante
Canada
Product Licence
Licence de mise en marché
Product Number/Numóro deproduit: 80015681
Brand Name/Ma rque nominative: Chloraseptic Sore Throat with Soothing Liquid Center
Issued to/Emiso a:
Name of licensee/Nom du titulaire:
Medtech Products, Inc.
90 North Broadway
lrvington, New York, 10533
U.S.A.
Authorized for the following/Autorisó pour ce qul suit:
Dosage form/Forme posologique: Lozenge
Recommended route of administrationNole dadministratJon recommandée:
Buccal
Recommended dose/Dose recommandée:
Adults:
Take one lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the
mouth.
Children :
(6 years and older): Take one lozenge every 2 hours as needed. Allow lozenges to dissolve
slowly in the mouth.
Child ren :
(under years of age): Consult a doctor.
Recommended duration of use/Durêe d'uti!isation recommandêe:
N/A
Recommended use or purpose/Usage ou Ies fins recommandós:
Oral Anesthetic/Analgesic lozenges. Temporarily relieves throat pain. Temporarily relieves: pain of sore throat, coughs. Helps
ease/relieve nasal congestion, makes nasal passages feel clearer.
Risk Information/Renseignements sur los risques:
Cautions and Warnings
Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine,
benzocaine or other "cain& anesthetics. Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied
by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. If symptoms are severe or persist
for more than 2 days consult a doctor. If cough worsens, persists for more than 7 days, or is accompanied by a high fever
consult a doctor. When using this product: do not exceed recommended dosage. Stop use and ask a doctor if: irritation, pain
or redness persists or worsens, swelling, rash or fever develops. If pregnant or breast-feeding: ask a health care practitioner
before use. Keep out of reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison
Control Centre right away.
Medicinal Ingredients/Ingródients mêdicinaux:
Quantity per
Proper Name
Common Name
Dosage Unit
Nom propre
Nom usuel
Quantité par unite
posologique
Extract
Extra it
Potency
Activité
Source Material
Matiôre d'orig!ne
Benzocaine
Benzocaine
6 mg
N/A
N/A
Benzocaine (Synthetic)
Menthol
Menthol
10 mg
N/A
N/A
Mentha arvensis oil
2010/02/05 2:58:22 PM
Health
Canada
5/13
Sante
Canada
Product Number/Numéro deproduit: 80015681
Brand NamelMarque nominative: Chloraseptic Sore Throat with Soothing Liquid Center
This licence is issued by the Minister of Health under the authority of section 7 of the Natural Health Products Regulations. Sale of
the described natural health product, including any changes thereto pursuant to section 11 of the Regulations, is subject to the
Food and Drugs Act and to the Natural Health Products Regulations.
Cetto licence est émise par Ia ministre do Ia Sante en vertu do l'article 7 du Réglement sur los produits de sante naturels.
La vente du produit de sante naturel décrit dans Ia présente, y compris toute modification afférente au sens de I'article 11 du
Réglement, est assujettie a Ia Loi sur los aliments et drogues et au Réglement sur los produits de sante naturals.
lssued/emis le: 201002-04
Revised/Amended/Modifié le: N/A
Director Ge nerallD/rectrice générale
NHPDIDPSN