Topicaine 5 (Lidocaine 5%) Gel [Esba Laboratories Inc.] -

TOPICAINE 5 (LIDOCAINE 5%) GEL [ESBA LABORATORIES INC.]
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NDC	63135-581-04, 63135-581-13, 63135-581-30
Set ID	15d33ff7-34ed-253d-e054-00144ff88e88
Category	HUMAN OTC DRUG LABEL
Packager	ESBA LABORATORIES INC.
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART346

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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

Labeling printed on tube of Topicaine 5% 10 g

Outer carton of Topicaine 5% 10 g tube

Label affixed to tube of Topicaine 5 % 30 g tube

Outer carton of Topicaine 5 % 30 g tube:

Label affixed to tube to Topicaine 5% 113 g

INGREDIENTS AND APPEARANCE

TOPICAINE 5
lidocaine 5% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63135-581
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63135-581-30	1 in 1 BOX	04/20/2003
1		30 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:63135-581-13	1 in 1 BOX	04/20/2003
2		10 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:63135-581-04	113 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2008