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NDC 72188-0076-59 MAXOCAINE Topical Anesthetic Anorectal 50 mg/mL Details

MAXOCAINE Topical Anesthetic Anorectal 50 mg/mL

MAXOCAINE Topical Anesthetic Anorectal is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by PRIME COMMERCE, LLC. The primary component is LIDOCAINE.

Product Information

NDC	72188-0076
Product ID	72188-076_adde2f53-b47e-c1ed-e053-2a95a90ab8b4
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	MAXOCAINE Topical Anesthetic Anorectal
Proprietary Name Suffix	n/a
Non-Proprietary Name	LIDOCAINE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	50
Active Ingredient Units	mg/mL
Substance Name	LIDOCAINE
Labeler Name	PRIME COMMERCE, LLC
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2022-12-31

Package

Package Images

NDC 72188-0076-59 (72188007659)

Pricing Information	N/A
NDC Package Code	72188-076-59
Billing NDC	72188007659
Package	59 mL in 1 JAR (72188-076-59)
Marketing Start Date	2020-09-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 26e8c867-8cb8-4a25-91b1-da45a1edd09a Details

Drug Facts

Active Ingredient:

Lidocaine 5.0% w/w

Purpose

Topical Anesthetic

Use(s):

For the temporary relief of pain and discomfort associated with anorectal disorders.

Warnings:

For external use only
Avoid contact with eyes.
Do not exceed recommended daily dosage unless directed by physician.

Stop use and consult physician

if rectal bleeding occurs, if allergic reaction develops, if condition worsens or does not improve within seven days.

Keep out of reach of children.

If swallowed, consult physician.

Directions:

When practical, cleanse the affected area with mild soap and warm water, then rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.

Adults and children 12-years and over: apply externally to the affected area up to five times per day.
Children under 12-years: Consult a physician.

Other Ingredients:

Acrylates C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionzied Water), Arnica Montana Extract, Boswellia Serrata Extract, Cannabis Sativa (Hemp) Seed Oil, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Ilex Paraguariensis (Yerba Mate) Extract, Isopropyl Myristate, methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Stearic Acid, Triethanolamine.

Package Labeling:

INGREDIENTS AND APPEARANCE

MAXOCAINE TOPICAL ANESTHETIC ANORECTAL

lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72188-076
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72188-076-59	59 mL in 1 JAR; Type 0: Not a Combination Product	09/05/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	09/05/2020

Labeler - PRIME COMMERCE, LLC (016785608)

Revised: 8/2020

Document Id: adde2f53-b47e-c1ed-e053-2a95a90ab8b4

Set id: 26e8c867-8cb8-4a25-91b1-da45a1edd09a

Version: 2

Effective Time: 20200827