Label: PRIME-GEL- benzocaine gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77794-018-00, 77794-018-17 - Packager: Prime Dental Manufacturing, 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 April 30, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
- List of Inactive Ingredients
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- ACTIVE INGREDIENT
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WARNINGS AND PRECAUTIONS
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 occures, 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 swaloowed, get medical help or contact a posion control center immediately.
If pregnant or breast feeding, ask a health care proffesional before use.
Keep out of reach of children.
- QUESTIONS
- PREGNANCY OR BREAST FEEDING
- ASK DOCTOR/PHARMACIST
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WARNINGS
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 occures, 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 swaloowed, get medical help or contact a posion control center immediately.
If pregnant or breast feeding, ask a health care proffesional before use.
Keep out of reach of children.
- Package Labelling
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INGREDIENTS AND APPEARANCE
PRIME-GEL
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77794-018 Route of Administration PERIODONTAL, DENTAL, ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 0.2 g in 1 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 0.69 g in 1 g HC RED NO. 3 (UNII: 51CPX7M1SQ) 0.0006 g in 1 g SACCHARIN (UNII: FST467XS7D) 0.045 g in 1 g POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 0.05 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77794-018-00 24 in 1 BOX, UNIT-DOSE 12/15/2020 1 NDC:77794-018-17 29.6 g in 1 BOTTLE; 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 12/15/2020 Labeler - Prime Dental Manufacturing, Inc. (083614037) Establishment Name Address ID/FEI Business Operations Prime Dental Manufacturing, Inc. 083614037 manufacture(77794-018)
