MAXOCAINE Topical Anesthetic Anorectal

MAXOCAINE Topical Anesthetic Anorectal by

Drug Labeling and Warnings

MAXOCAINE Topical Anesthetic Anorectal by is a Otc medication manufactured, distributed, or labeled by PRIME COMMERCE, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MAXOCAINE TOPICAL ANESTHETIC ANORECTAL- lidocaine cream 
PRIME COMMERCE, LLC

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MAXOCAINE Topical Anesthetic Anorectal

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:

MAXOCAINE TOPICAL ANESTHETIC ANORECTAL 
lidocaine cream

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72188-076-59	59 mL in 1 JAR; Type 0: Not a Combination Product	09/05/2020	09/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	09/05/2020	09/30/2021

Labeler - PRIME COMMERCE, LLC (016785608)

Revised: 10/2023

Document Id: 07418098-3dfd-341e-e063-6394a90a84dd

34390-5

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

Version: 3

Effective Time: 20231008