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NDC 59088-0587-16 PharmapureRx Menthotral 38.8; 30 mg/mL; mg/mL Details

PharmapureRx Menthotral 38.8; 30 mg/mL; mg/mL

PharmapureRx Menthotral is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by PureTek Corporation. The primary component is LIDOCAINE HYDROCHLORIDE ANHYDROUS; MENTHOL.

Product Information

NDC	59088-0587
Product ID	59088-587_9f30958e-2a0e-4a06-a834-1cba30bdf3c3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	PharmapureRx Menthotral
Proprietary Name Suffix	n/a
Non-Proprietary Name	lidocaine, menthol
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	38.8; 30
Active Ingredient Units	mg/mL; mg/mL
Substance Name	LIDOCAINE HYDROCHLORIDE ANHYDROUS; MENTHOL
Labeler Name	PureTek Corporation
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59088-0587-16 (59088058716)

Pricing Information	N/A
NDC Package Code	59088-587-16
Billing NDC	59088058716
Package	237 mL in 1 BOTTLE, PUMP (59088-587-16)
Marketing Start Date	2017-08-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d2a9aeb6-8a94-49e7-ab46-84403560b6c8 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - PureTek Corporation (785961046)

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

Revised: 3/2019

Document Id: 9f30958e-2a0e-4a06-a834-1cba30bdf3c3

Set id: d2a9aeb6-8a94-49e7-ab46-84403560b6c8

Version: 2

Effective Time: 20190305