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Topcare Maximum Strength

Medically reviewed on Oct 8, 2018

Dosage form: liquid
Ingredients: BENZOCAINE 20g in 100g
Labeler: Topco
NDC Code: 36800-443

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 Facts

Active ingredient

Benzocaine 20.0% (w/w)...................................................................... Oral anesthetic

Uses

Temporarily relieves pain associated with the following mouth and gum irritations: •toothache •sore gums •canker sores •braces •minor dental procedures

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

When using this product •avoid contact with eyes •do not exceed recommended dosage •do not use for more than 7 days unless directed by a dentist or doctor

Stop use and ask doctor or dentist if •sore mouth symptoms do not improve in 7 days •irritation, pain or redness persists or worsens •swelling, rash or fever develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older:

      •apply to affected area using applicator tip

      •use 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 this product

children under 2 years of age: consult a dentist or doctor

• use 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 this product • children under 2 years of age: consult a dentist or doctor

Other Information

do not use if package has been opened
store at 20 - 25 C (68-77F)
close cap tightly after use to avoid evaporation
avoid contact with eyes
avoid contact with clothing and household furniture surfaces to avoid possible staining
this is a personal care item, and should be used by one individual only

Inactive ingredients

Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Methylparaben, Natural and Artifical Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water



Bottle


Blister

TOPCARE  MAXIMUM STRENGTH
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-443
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
SACCHARIN SODIUM 
PROPYLENE GLYCOL 
METHYLPARABEN 
BENZYL ALCOHOL 
WATER 
FD&C RED NO. 40 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
Product Characteristics
Colorred (dark orange/red to sl brown) Score    
ShapeSize
FlavorMINT (N&A Mint Flavor 619179) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-443-481 BOTTLE, WITH APPLICATOR (BOTTLE) in 1 BLISTER PACK
1NDC:36800-443-4114.17 g in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B10/01/2014
Labeler - Topco (006935977)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIOperations
CSR Cosmetic Solutions243501959manufacture(36800-443), pack(36800-443)

 
Topco

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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