TOPICAINE 5- lidocaine 5% gel 
ESBA LABORATORIES INC.

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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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

Label on tube and outer carton

Labeling printed on tube of Topicaine 5% 10 g

Printed tube of Topicaine 5% 10 grams

Outer carton of Topicaine 5% 10 g tube

Outer carton of Topicaine 5% 10 g tubes

Label affixed to tube of Topicaine 5 % 30 g tube

TOP5-030 label

Outer carton of Topicaine 5 % 30 g tube:

Topicaine 5 30 g outer carton update

Label affixed to tube to Topicaine 5% 113 g

Label of tube of Topicaine 5% 113 g

TOPICAINE 5 
lidocaine 5% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63135-581
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 5 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X) 2 g  in 100 g
BENZYL ALCOHOL (UNII: LKG8494WBH) 0.8 g  in 100 g
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) 1 g  in 100 g
SHEA BUTTER (UNII: K49155WL9Y) 2.5 g  in 100 g
EDETATE DISODIUM (UNII: 7FLD91C86K) 0.025 g  in 100 g
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) 0.6 g  in 100 g
GLYCERYL LAURATE (UNII: Y98611C087) 2.5 g  in 100 g
ALCOHOL (UNII: 3K9958V90M) 36.75 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63135-581-301 in 1 BOX04/20/2003
130 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:63135-581-101 in 1 BOX04/20/2003
210 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:63135-581-04113 g in 1 TUBE; Type 0: Not a Combination Product03/01/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/20/200312/31/2025
Labeler - ESBA LABORATORIES INC. (963303490)
Registrant - ESBA LABORATORIES INC. (963303490)
Establishment
NameAddressID/FEIBusiness Operations
ESBA LABORATORIES INC.963303490manufacture(63135-581)

Revised: 7/2023
Document Id: 008977e2-cdc2-9f04-e063-6394a90a1dbf
Set id: 15d33ff7-34ed-253d-e054-00144ff88e88
Version: 9
Effective Time: 20230715
 
ESBA LABORATORIES INC.