PHARMAPURERX MENTHOTRAL- lidocaine, menthol cream

PharmapureRx Menthotral by

Drug Labeling and Warnings

PharmapureRx Menthotral by is a Otc medication manufactured, distributed, or labeled by PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (% w/w)

Lidocaine 3.88%

Menthol 3%

Purposes

Topical Anesthetic (Lidocaine 3.88%)
Topical Analgesic (Menthol 3%)

Uses

for the temporary relief of minor pain, itching and irritation due to / associated with
■ simple backache   ■ arthritis   ■ sprains   ■ muscle strains   ■ bruises
■ minor cuts/scrapes   ■ minor burns/sunburn   ■ insect bites

Warnings

For external use only

Do not use

■ if allergic to lidocaine or any other local anesthetics
■ over a large skin area   ■ on deep puncture wounds   ■ on infections
■ on raw surfaces or blistered areas

When using this product

■ do not get into eyes   ■ do not use in large quantities
■ do not bandage or apply heat to treated areas
■ wash hands immediately after using

Stop use and ask a doctor if

■ condition worsens
■ symptoms last more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ Adults and children over 12 years of age: apply a thin layer to the affected area up to 3 to 4 times a day
■ Children 12 years of age or younger: consult a doctor

Other information

■ keep container tightly closed   ■ store at 20° to 25°C (68° to 77°F)

Inactive ingredients

Aminomethyl Propanol, Carbomer, Ceteareth-20, Cetyl Ethylhexanoate, Cetyl Phosphate, Diisobutyl Adipate, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate SE, Phenoxyethanol, Purified Water, Stearic Acid.

PRINCIPAL DISPLAY PANEL

PharmapureRx® Menthotral™ Cream (Lidocaine 3.88% / Menthol 3%)

Topical Use Only

Manufactured in the USA by:
PureTek Corporation
San Fernando, CA 91340
877-921-7873

INGREDIENTS AND APPEARANCE

PHARMAPURERX MENTHOTRAL 
lidocaine, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59088-587
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	38.8 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CETYL PHOSPHATE (UNII: VT07D6X67O)
DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-587-16	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/03/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/03/2017

Labeler - PureTek Corporation (785961046)

Establishment
Name	Address	ID/FEI	Business Operations
PureTek Corporation		785961046	manufacture(59088-587)