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PharmapureRx Menthotral

Medically reviewed on August 3, 2017.

Dosage form: cream
Ingredients: LIDOCAINE HYDROCHLORIDE ANHYDROUS 38.8mg in 1mL, MENTHOL 30mg in 1mL
Labeler: PureTek Corporation
NDC Code: 59088-587

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

Topical Use Only

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.

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

PHARMAPURERX MENTHOTRAL 
lidocaine, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-587
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS38.8 mg  in 1 mL
MENTHOL (MENTHOL) MENTHOL30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
POLYOXYL 20 CETOSTEARYL ETHER 
CETYL ETHYLHEXANOATE 
CETYL PHOSPHATE 
DIISOBUTYL ADIPATE 
EDETATE DISODIUM 
GLYCERIN 
GLYCERYL STEARATE SE 
PHENOXYETHANOL 
WATER 
STEARIC ACID 
Packaging
#Item CodePackage Description
1NDC:59088-587-16237 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/03/2017
Labeler - PureTek Corporation (785961046)
Establishment
NameAddressID/FEIOperations
PureTek Corporation785961046manufacture(59088-587)

 
PureTek Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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