LEADER ORAL PAIN RELIEF ANESTHETIC- benzocaine 20% gel
Cardinal Health
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.
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For the temporary relief of minor toothache, pain and sore mouth associated with canker sores, dentures and orthodontic appliances.
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.
Keep Out of Reach of Children. In case of overdose, get medical help or contact a Poison Control Center right away.
Cut open tip of tube.
Adults and children 2 years of age and older, apply to affected area up to 4 times daily or as directed by a dentist or doctor.
Children under 12 years of age should be supervised in the use of the product.
Children under 2 years of age, consult a doctor.
LEADER ORAL PAIN RELIEF
ANESTHETIC
benzocaine 20% gel |
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Labeler - Cardinal Health (097537435) |
Registrant - Lee Pharmaceuticals (056425432) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Cardinal Health | 097537435 | label(37205-607) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Lee Pharmaceuticals | 056425432 | pack(37205-607) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Unipack | 009248480 | manufacture(37205-607) |