Alpha-caine Drug Facts, Mint

Alpha-caine Drug Facts, Mint
SPL v9
SPL
SPL Set ID ae628766-25b7-4b4f-abb8-a43faf2f44b9
Routes
PERIODONTAL DENTAL
Published
Effective Date 2018-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Polyethylene Glycol 400 Polyethylene Glycol 3350 Saccharin Sodium Fd&c Blue No. 1 D&c Yellow No. 10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1999-12-31

Description

Benzocaine 20%

Purpose

Oral Anesthetic


Medication Information

Purpose

Oral Anesthetic

Description

Benzocaine 20%

Uses

For the temporary relief of occasional minor irritation and pain, associated with:

  • Sore mouth and throat
  • Ulcers
  • Minor dental procedures
  • Needle punctures
  • Minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Warnings

For external use only

Do Not Use
  • for teething
  • in children under 2 years of age
directions

do not exceed recommended dosage.

  • adults and children 2 years of age and older: apply to affected area. Gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by dentist or doctor.
  • children under 12 years of age: should be supervised in the use of the product.
  • children under 2 years of age: do not use
Allergy Alert:

Do not use if you have a history of allergy to any “caine” anesthetics, such as benzocaine, butacaine, procaine or tetracaine.

Active Ingredient

Benzocaine 20%

Other Information

Store at 59° to 86º F (15º to 30º C)

Inactive Ingredients

Blue 1*, flavor, PEG-8, PEG-75, Red 3*, Red 33*, Red 40*, sodium saccharin, Yellow 10*

*contains one or more of these ingredients.

Sore Throat Warning:

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

Principal Display Panel

DENTAL

TECHNOLOGIES

www.dentaltech.com

ALPHA-CAINE

TOPICAL ANESTHETIC GEL

DENTAL TECHNOLOGIES, INC.

Lincolnwood, IL 60712

Made in U.S.A.

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

20% Benzocaine Oral Anesthetic

1oz. (30g)

When Using This Product

avoid contact with eyes

Methemoglobinemia Warning

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy
questions Or Comments?

1-800-835-0885 or 1-847-677-5500 M-F 8:00 a.m. – 4:30 p.m. CST.

Visit www.dentaltech.com

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact Poison Control Center right away.


Structured Label Content

Uses

For the temporary relief of occasional minor irritation and pain, associated with:

  • Sore mouth and throat
  • Ulcers
  • Minor dental procedures
  • Needle punctures
  • Minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Purpose

Oral Anesthetic

Warnings

For external use only

Do Not Use (Do not use)
  • for teething
  • in children under 2 years of age
directions (Directions)

do not exceed recommended dosage.

  • adults and children 2 years of age and older: apply to affected area. Gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by dentist or doctor.
  • children under 12 years of age: should be supervised in the use of the product.
  • children under 2 years of age: do not use
Allergy Alert: (Allergy alert:)

Do not use if you have a history of allergy to any “caine” anesthetics, such as benzocaine, butacaine, procaine or tetracaine.

Active Ingredient (Active ingredient)

Benzocaine 20%

Other Information (Other information)

Store at 59° to 86º F (15º to 30º C)

Inactive Ingredients (Inactive ingredients)

Blue 1*, flavor, PEG-8, PEG-75, Red 3*, Red 33*, Red 40*, sodium saccharin, Yellow 10*

*contains one or more of these ingredients.

Sore Throat Warning: (Sore throat warning:)

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

Principal Display Panel

DENTAL

TECHNOLOGIES

www.dentaltech.com

ALPHA-CAINE

TOPICAL ANESTHETIC GEL

DENTAL TECHNOLOGIES, INC.

Lincolnwood, IL 60712

Made in U.S.A.

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

20% Benzocaine Oral Anesthetic

1oz. (30g)

When Using This Product (When using this product)

avoid contact with eyes

Methemoglobinemia Warning (Methemoglobinemia warning)

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy
questions Or Comments? (Questions or comments?)

1-800-835-0885 or 1-847-677-5500 M-F 8:00 a.m. – 4:30 p.m. CST.

Visit www.dentaltech.com

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact Poison Control Center right away.


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Raw Label Data

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