MAXOCAINE TOPICAL ANESTHETIC- lidocaine hydrochloride cream

MAXOCAINE Topical Anesthetic by

Drug Labeling and Warnings

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

Drug Details [pdf]

DRUG FACTS:

Active Ingredient:

Lidocaine HCl 5.0%

Topical Analgesic

Use:

Relieves pain and discomfort associated with hemorrhoids and other 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 (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Cannabis Sativa (Full Spectrum Hemp) 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 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72188-066
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	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 (UNII: O80TY208ZW)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CANNABIS SATIVA WHOLE (UNII: B5ONF538PB)
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: 72188-066-00	59 mL in 1 JAR; Type 0: Not a Combination Product	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	08/01/2019

Labeler - Prime Commerce, LLC (016785608)