TOPICAINE- lidocaine 4% gel

TOPICAINE by

Drug Labeling and Warnings

TOPICAINE by is a Otc medication manufactured, distributed, or labeled by ESBA LABORATORIES INC., ESBA LABORATORIES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• allergic reaction occurs
• condition worsens or does not improve within 7 days
• symptoms clear up and return within a few days
• you notice any unusual effects

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:

Outer carton of Topicaine 4% 10 grams:

Label affixed to Topicaine 4% 30 gram tubes:

Outer box of Topicaine 4% 30 grams:

Label affixed to tubes of Topicaine 4% 113 grams:

INGREDIENTS AND APPEARANCE

TOPICAINE 
lidocaine 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63135-312
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63135-312-30	1 in 1 BOX	04/20/2003
1		30 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 63135-312-13	1 in 1 BOX	04/20/2003
2		10 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 63135-312-04	113 g in 1 TUBE; Type 0: Not a Combination Product	04/20/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	04/20/2003

Labeler - ESBA LABORATORIES INC. (963303490)

Registrant - ESBA LABORATORIES INC. (963303490)

Establishment
Name	Address	ID/FEI	Business Operations
ESBA LABORATORIES INC		963303490	manufacture(63135-312)