FDA Label for Walgreens Instant Toothache And Gum Relief Triple Medicated
View Indications, Usage & Precautions
Walgreens Instant Toothache And Gum Relief Triple Medicated Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
TAMPER EVIDENT: DO NOT USE IF TUBE TIP IS CUT PRIOR TO USE
Questions or comments? 1-800-925-4733
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com
Otc - Active Ingredient
Active ingredient
Benzocaine 20%
Menthol 0.25%
Zinc Chloride 0.15%
Otc - Purpose
Purpose
Oral pain reliever
Oral pain reliever
Astringent
Indications & Usage
Use
- for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums
Warnings
Warnings
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
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
Otc - Do Not Use
Do not use
- more than directed
- for more than 7 days unless directed by a dentist or doctor
- for teething
- in children under 2 years of age
Otc - Stop Use
Stop use and ask a doctor if
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days
- allergic reaction occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- cut open tip of tube on score mark
- adults and children 2 years of age and older: apply a small amount of the product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor.
- children under 12 years of age should be supervised in the use of this product
- children under 2 years of age: do not use
Other Safety Information
Other information
- do not use if tip is cut prior to opening
- this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
- do not use continuously
- this formula will stay in place for extended duration of relief
- avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
Inactive Ingredient
Inactive ingredientscellulose gum, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin
Package Label.Principal Display Panel
Walgreens
Instant Toothache & Gum relief
ORAL PAIN RELIEVER/ASTRINGENT
SEVERE CREAM TRIPLE MEDICATED
- 20% benzocaine to relieve oral pain
- astringent to relieve gum irritation
- menthol to soothe
NET WT 0.33 OZ (9.4g)
* Please review the disclaimer below.