- Active Ingredients
- Purpose
- Uses
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Warnings
For oral use only. 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 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. If a skin reaction occurs, stop use and seek medical help right away.
When using this product
Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage.
- Directions
- Other Information
- Inactive ingredients
- Questions or Comments?
- Principal Display Panel - Safetec Oral Pain Relief Carton Label
- Principal Display Panel - Safetec Oral Pain Relief Packet Label
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INGREDIENTS AND APPEARANCE
PAIN RELIEF
benzocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-8100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine 200 mg in 1 g Inactive Ingredients Ingredient Name Strength polyethylene glycol 400 (UNII: B697894SGQ) polyethylene glycol 3350 (UNII: G2M7P15E5P) peppermint oil (UNII: AV092KU4JH) saccharin sodium (UNII: SB8ZUX40TY) sorbic acid (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61010-8100-2 0.5 g in 1 PACKET; Type 0: Not a Combination Product 02/01/2019 2 NDC:61010-8100-1 144 in 1 BOX 02/01/2019 2 0.75 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/01/2010 Labeler - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec Of America, Inc. 874965262 MANUFACTURE(61010-8100)