Label: DENTAL RELIEF- benzocaine liquid
- NDC Code(s): 68421-8100-2, 68421-8100-3, 68421-8100-4
- Packager: Cintas First Aid & Safety
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 27, 2014
If you are a consumer or patient please visit this version.
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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:68421-8100 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:68421-8100-3 10 in 1 BAG 05/06/2016 1 NDC:68421-8100-2 0.5 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:68421-8100-4 500 in 1 BOX 05/06/2016 2 NDC:68421-8100-2 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 not final part356 05/06/2016 Labeler - Cintas First Aid & Safety (056481716) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec Of America, Inc. 874965262 MANUFACTURE(68421-8100)