Label: DENTARIN- benzocaine 20% solution
- NDC Code(s): 69469-200-30
- Packager: Vitamex USA, Corp.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated August 27, 2024
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- Official Label (Printer Friendly)
- Active Ingredients:
- Uses:
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Warnings: Methemoglobinemia warning:
Warnings: Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condiiton tha tmust 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 pal, gray, or blue colored skin cyanosis), headache, rapid heartbeat, shortness of breath, diziness or lightheadedness, fatigue or lack of enerygy. Keep away from eyes.
- Allergy alert
- Flammability warning
- Do not use
- Stop use and ask a doctor if
- If pregnant or breastfeeding
- Keep out of reach of children
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Directions:
Adults and children 2 years of age older | Apply to affected area up to 4 times daily or as directed by 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 Directions: Spray a small amount of product around the affected area up to 4 times daily.
- Other information
- Inactive ingredients
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Doseage and administration
Adults and children 2 years of age older | Apply to affected area up to 4 times daily or as directed by 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 useDirections: Spray a small amount of product around the affected area up to 4 times daily.
- Dentarin
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INGREDIENTS AND APPEARANCE
DENTARIN
benzocaine 20% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69469-200 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 mL Inactive Ingredients Ingredient Name Strength CLOVE OIL (UNII: 578389D6D0) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69469-200-30 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 08/01/2024 Labeler - Vitamex USA, Corp. (054256676)