Label: DENTAL RELIEF- benzocaine liquid
- NDC Code(s): 42961-810-02, 42961-810-03, 42961-810-04
- Packager: Cintas Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 28, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
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Warnings
For oral use only
Allergy alert
Do not use this product if you have a history of allergy to local anaesthetics, such as procaine, butacaine, benzocaine, or other “caine” anaesthetics due to the possibility of anaphylactic shock.
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.
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Directions
- Adults and children 2 years and older: dry affected area and apply medication undiluted; Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor
- Consult a dentist or doctor for use on children under 2 years of age
- Children under 12 years of should be supervised in the use of this product
- Other information
- Inactive Ingredients
- Principal Display Panel – 0.5 gram Packet
- Principal Display Panel – Pocket Card
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INGREDIENTS AND APPEARANCE
DENTAL RELIEF
benzocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-810 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:42961-810-03 10 in 1 BAG 04/08/2021 1 NDC:42961-810-02 0.5 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:42961-810-04 500 in 1 BOX 04/08/2021 2 NDC:42961-810-02 0.5 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 Drug M022 04/08/2021 Labeler - Cintas Corporation (056481716) Establishment Name Address ID/FEI Business Operations Safetec Of America, Inc. 874965262 MANUFACTURE(42961-810)