TOPICAINE- lidocaine 4% 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

Active ingredient

Lidocaine 4% w/w

Purpose

Topical Anesthetic

Uses

For the temporary relief of pain.

Warnings

For external use only

Flammable

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

Stop use and ask a doctor if:

Keep out of the reach of children

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

Directions

Apply externally to affected area up to 3 to 4 times a day. Children under 2 years of age consult a doctor.

Inactive Ingredients

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

Questions

Call toll-free in USA & Canada 800-677-9299 or visit www.topicaine.com

Labelling on tubes and outer cartons

Labelling printed on tube of Topicaine 4% 10 gram tube:

Printing on the tube of Topicaine 4% 10 g

Outer carton of Topicaine 4% 10 grams:

Box of Topicaine 4% 10 grams

Label affixed to Topicaine 4% 30 gram tubes:

Label affixed to tubes of Topicain 4% 30 grams

Outer box of Topicaine 4% 30 grams:

Box for Topicaine 4% 30 gram tubes

Label affixed to tubes of Topicaine 4% 113 grams:

Labels Topicaine 4% 113 gram tubes

TOPICAINE 
lidocaine 4% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63135-312
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 44.534 g  in 100 g
CARBOMER 940 (UNII: 4Q93RCW27E) 0.6 g  in 100 g
ALCOHOL (UNII: 3K9958V90M) 36.842 g  in 100 g
JOJOBA OIL (UNII: 724GKU717M) 2.5 g  in 100 g
GLYCERYL LAURATE (UNII: Y98611C087) 2 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X) 2.5 g  in 100 g
BENZYL ALCOHOL (UNII: LKG8494WBH) 2 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 5 g  in 100 g
EDETATE DISODIUM (UNII: 7FLD91C86K) 0.024 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63135-312-301 in 1 BOX04/20/2003
130 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:63135-312-131 in 1 BOX04/20/2003
210 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:63135-312-04113 g in 1 TUBE; Type 0: Not a Combination Product04/20/2003
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)
Establishment
NameAddressID/FEIBusiness Operations
ESBA LABORATORIES INC963303490manufacture(63135-312)

Revised: 12/2021
Document Id: d29559f4-5d48-2357-e053-2a95a90a37d5
Set id: 7f96e980-891e-743d-e053-2a91aa0aea5f
Version: 3
Effective Time: 20211207
 
ESBA LABORATORIES INC.