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NDC 63868-0953-11 Quality Choice Maximum Strength Oral Pain Relieving 20 g/100g Details
Quality Choice Maximum Strength Oral Pain Relieving 20 g/100g
Quality Choice Maximum Strength Oral Pain Relieving is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association Inc. The primary component is BENZOCAINE.
Product Information
NDC | 63868-0953 |
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Product ID | 63868-953_db8b08a6-4b69-4e2b-e053-2a95a90a79eb |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Quality Choice Maximum Strength Oral Pain Relieving |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | BENZOCAINE |
Product Type | HUMAN OTC DRUG |
Dosage Form | GEL |
Route | TOPICAL |
Active Ingredient Strength | 20 |
Active Ingredient Units | g/100g |
Substance Name | BENZOCAINE |
Labeler Name | Chain Drug Marketing Association Inc |
Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part356 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 63868-0953-11 (63868095311)
NDC Package Code | 63868-953-11 |
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Billing NDC | 63868095311 |
Package | 1 TUBE in 1 CARTON (63868-953-11) / 11.76 g in 1 TUBE |
Marketing Start Date | 2013-05-31 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL dbde8e7f-85d8-4083-b01a-3a7e410a7747 Details
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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 your child has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
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Adults and children 2 years of age and older. |
Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around 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. |
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INGREDIENTS AND APPEARANCE
QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING
benzocaine gel |
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Labeler - Chain Drug Marketing Association Inc (011920774) |