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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

Prime Commerce, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

MAXOCAINE PAIN RELIEVING ROLL-ON- LIDOCAINE HYDROCHLORIDE,
MENTHOL LIQUID
PRIME COMMERCE, LLC
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MAXOCAINE PAIN RELIEVING ROLL-ON
_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:_
 Apply to affected area not more than three to four times daily.
consult a physician.
ADULTS AND CHILDREN TWO-YEARS OF AGE OR OLDER:CHINLDREN UNDER
TWO-YEARS OF
AGE:
_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:
MAXOCAINE PAIN RELIEVING ROLL-ON
lidocaine hydrochloride, menthol liquid
PRODUCT INFORMATION
Prime Commerce, LLC
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)