Label: ADVENTURE MEDICAL KITS DENTAL MEDIC- benzocaine kit
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Contains inactivated NDC Code(s)
NDC Code(s): 44224-0102-0, 61010-8100-2 - Packager: Tender Corporation
- 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 March 16, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient - Oral Pain Relief
- Purpose - Oral Pain Relief
- Uses - Oral Pain Reliever
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Warnings - Oral Pain Relief
For oral use only. Avoid contact with eyes.
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 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.
Keep out of reach of children
If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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Directions - Oral Pain Relief
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 age should be supervised in the use of this product
- Other Information - Oral Pain Relief
- Inactive Ingredients - Oral Pain Relief
- Keep out of Reach of Children
- Adventure Medical Kits Dental Medic
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INGREDIENTS AND APPEARANCE
ADVENTURE MEDICAL KITS DENTAL MEDIC
benzocaine kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44224-0102 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44224-0102-0 1 in 1 BAG; Type 0: Not a Combination Product 09/19/2012 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 4 PACKET 2 g in .5 Part 1 of 1 PAIN RELIEF
benzocaine liquidProduct Information Item Code (Source) NDC:61010-8100 Route of Administration TOPICAL, ORAL 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 PEPPERMINT OIL (UNII: AV092KU4JH) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/19/2012 Labeler - Tender Corporation (064437304) Registrant - Tender Corporation (064437304) Establishment Name Address ID/FEI Business Operations Tender Corporation 064437304 manufacture(44224-0102)
