MAXOCAINE PAIN RELIEVING ROLL-ON- lidocaine hydrochloride, menthol liquid

MAXOCAINE PAIN RELIEVING ROLL-ON by

Drug Labeling and Warnings

MAXOCAINE PAIN RELIEVING ROLL-ON 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

Lydocaine HCL 4%

Menthol 1%

Purpose

Topical anesthetic

Use:

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

Warnings:

• For external use only
• Avoid contact with eyes.
• If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

If swallowed, consult physician.

Do not apply

• to wounds or damaged skin.
• Do not bandage tightly.

If pregnant or breast feeding,

contact physician prior to use.

Directions:

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.  Chinldren under two-years of age: consult a physician.

Additional Information:

Store at room temperature.

Inactive Information:

Acrylates C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Cetyl Alcohol, Ethylhexylglycerin, Ilex Paraguayensis (Yerba Mate') Extract, Isopropyl Alcohol, Isopropyl Myristate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Sodium Lauryl Sulfate, Stearic Acid, Triethanolamine

Package Labeling:

INGREDIENTS AND APPEARANCE

MAXOCAINE PAIN RELIEVING ROLL-ON 
lidocaine hydrochloride, menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72188-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	40 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72188-170-03	88 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2018

Labeler - Prime Commerce, LLC (016785608)