Label: VISTACAINE TOPICAL ANESTHETIC- benzocaine gel
- NDC Code(s): 64522-002-30
- Packager: Inter-Med, INC.
- 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 January 24, 2022
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- Official Label (Printer Friendly)
- Active Ingredients (in each gram)
- Purpose
- Use
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Warnings
- Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.
- 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; irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.
- When using this product avoid contact with eyes. If contact occurs, flush with water.
- Stop use and consult a health care practitioner if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.
- Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
- If pregnant or breast feeding, ask a health professional before use.
- Keep Out of Reach of Children.
- Directions
- Other Information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VISTACAINE TOPICAL ANESTHETIC
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64522-002 Route of Administration 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 3350 (UNII: G2M7P15E5P) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color green Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64522-002-30 30 g in 1 JAR; Type 0: Not a Combination Product 02/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 02/01/2018 Labeler - Inter-Med, INC. (036623932)
