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TOPICAINE 5

Dosage form: gel
Ingredients: LIDOCAINE 5g in 100g
Labeler: ESBA LABORATORIES INC.
NDC Code: 63135-581

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.

TOPICAINE 5

Active Ingredient

Lidocaine 5% w/w

Purpose

Topical Anesthetic

Uses

For the temporary relief of pain and itching due to anorectal disorders.

Warnings

For external use only

Flammable Keep away from sparks, heat and fire. Cap tube tightly when not in use.

When using this product
  • avoid contact with eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
  • do not put in rectum
  • do not exceed recommended dosage unless directed by a doctor

Stop use and ask a doctor if:
  • allergic reaction occurs
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase.

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Bisabolol, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Laurate, SD Alcohol 40, Shea Butter, Simmondsia Chinensis (Jojoba) Seed Oil, Water.

Directions
  • When practical, clean area with mild soap and warm water and rinse thoroughly
  • Gently dry by patting or blotting with toilet tissue or soft cloth before applying
  • Adults and children 12 years old and older: Apply externally to the affected area up to 6 times a day
  • Children under 12 years of age: consult a doctor.

Label on tube and outer carton

Label on tube of Topicaine 5 % 30 g tube

Outer carton of Topicaine 5 % 30 g tube:

TOPICAINE 5 
lidocaine 5% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63135-581
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN5 g  in 100 g
ALOE VERA LEAF2 g  in 100 g
BENZYL ALCOHOL0.8 g  in 100 g
.ALPHA.-BISABOLOL, (+/-)-1 g  in 100 g
EDETATE DISODIUM0.025 g  in 100 g
CARBOMER 9400.6 g  in 100 g
GLYCERYL LAURATE2.5 g  in 100 g
ALCOHOL36.75 g  in 100 g
SHEA BUTTER2.5 g  in 100 g
Packaging
#Item CodePackage Description
1NDC:63135-581-301 TUBE in 1 BOX
130 g in 1 TUBE
2NDC:63135-581-131 TUBE in 1 BOX
210 g in 1 TUBE
3NDC:63135-581-04113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/20/2003
Labeler - ESBA LABORATORIES INC. (963303490)
Registrant - ESBA LABORATORIES INC. (963303490)

Revised: 06/2015
 
ESBA LABORATORIES INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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