FDA Label for Walgreens Pain Relief
View Indications, Usage & Precautions
Walgreens Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens Company. 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
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.
Active Ingredient
Benzocaine 20%
Purpose
Oral Pain Reliever
Uses
- temporary relief of occasional minor irritation, pain and sore mouth
Do Not Use
- more than directed
- for more than 7 days unless told to do so by a dentist or doctor
Stop Use And Ask A Doctor If
- swelling, rash or fever develops
- irritation, pain, or redness persists or worsens
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.
Directions
- do not use tube if it is cut prior to opening
- cut open tip of tube on score mark
- use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel
- apply to affected area up to four times daily or as directed by a dentist or physician
- Adults and children 2 years of age and older: Apply to affected area
- Children under 12 years of age should be supervised in the use of this product
- Children under 2 years of age: Consult a doctor
Other Information
- store at a controlled room temperature 59°-86°F (15°-30°C)
Inactive Ingredients
Benzyl Alcohol, Carbomer, D&C YellowNo.10, FD&C Blue No1, FD&C Red No 40, Glycerin, Methylparaben, Propylparaben, Polyethlene Glycol, Propylene Glycol, Sodium Saccharin
Principal Display Panel – 0.33Oz Carton Label
Walgreens NDC 0363-5061-33
Oral Pain Relief
Maxium Strength GEL
Fast Toothache Pain Reliever
20% Benzocaine Topical Gel
NET WT. 0.33 OZ (9.35g)
Made in the USA
Principal Display Panel – 0.33Oz Tube Label
Walgreens NDC 0363-5061-33
Oral Pain Relief
Maxium Strength GEL
Fast Toothache Pain Reliever
20 % Benzocaine Topical Gel
Made in the USA
NET WT. 0.33 OZ (9.35g)
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