Label: ALPHA-CAINE TOPICAL ANESTHETIC- benzocaine gel
- NDC Code(s): 55346-2902-1
- Packager: Dental Technologies, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 20, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
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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 medical 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:
- Sore throat warning:
- Do not use
- When using this product
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
do not exceed recommended dosage.
- adults and children 2 years of age and older: apply to affected area. Gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out. Use 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 the product.
- children under 2 years of age: do not use
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ALPHA-CAINE TOPICAL ANESTHETIC
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55346-2902 Route of Administration PERIODONTAL, DENTAL 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) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Product Characteristics Color Score Shape Size Flavor MINT (Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55346-2902-1 30 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/31/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 12/31/1999 Labeler - Dental Technologies, Inc. (148312838) Registrant - Dental Technologies, Inc. (148312838) Establishment Name Address ID/FEI Business Operations Dental Technologies, Inc. 148312838 manufacture(55346-2902) , pack(55346-2902) , label(55346-2902)