LIPOCAINE 5- lidocaine 5% cream

LIPOCAINE 5 by

Drug Labeling and Warnings

LIPOCAINE 5 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 5%

Purpose

Topical Anesthetic

Use

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

Warnings

For external use only.

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 (1-800-222-1222).

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.

Other information:

• Store at room temperature 20-25oC (68-77oF).
• Child-Resistant Cap: push down and turn to open
• Available in 1 Oz (30 g) and 4 Oz (113 g) tubes

Inactive ingredients:

Allantoin, Aloe Barbadensis Leaf Extract, Beta-Sitosterol, Caprylhydroxamic Acid, Cetyl Alcohol, Cetyl Palmitate, Glycerin, Glyceryl Caprylate, Isostearyl Alcohol, Lecithin, Purified Water, Sucrose Distearate, Sucrose Stearate , Tocopheryl Acetate, Triethylcitrate, Xanthan Gum.

Questions

Call toll-free in USA & Canada 800-677-9299 9 am - 5 pm (EST) M - F or visit www.esbalabs.com

Label on tube and outer carton

Lipocaine 5 tube 113 grams label

Lipocaine 5 tube 30 grams label

Outer carton of Lipocaine 5 - 30 g tube

INGREDIENTS AND APPEARANCE

LIPOCAINE 5 
lidocaine 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63135-811
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)	0.01 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE)	1.5 g  in 100 g
SUCROSE DISTEARATE (UNII: 33X4X4B90S)	2 g  in 100 g
.BETA.-SITOSTEROL (UNII: S347WMO6M4)	0.5 g  in 100 g
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)	0.12 g  in 100 g
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)	0.6 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	0.48 g  in 100 g
CETYL PALMITATE (UNII: 5ZA2S6B08X)	5 g  in 100 g
CETYL ALCOHOL (UNII: 936JST6JCN)	0.25 g  in 100 g
WATER (UNII: 059QF0KO0R)	71.77 g  in 100 g
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)	0.25 g  in 100 g
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)	0.01 g  in 100 g
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)	10 g  in 100 g
SUCROSE STEARATE (UNII: 274KW0O50M)	2 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)	0.5 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.01 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63135-811-30	1 in 1 CARTON	03/18/2019
1		30 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 63135-811-04	113 g in 1 TUBE; Type 0: Not a Combination Product	03/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	03/18/2019

Labeler - ESBA LABORATORIES INC. (963303490)

Registrant - Esba Laboratories Inc (963303490)

Establishment
Name	Address	ID/FEI	Business Operations
ESBA LABORATORIES INC.		963303490	manufacture(63135-811)