LIDOZEN- lidocaine hydrochloride, menthol patch

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
01-10-2019

Aktiv ingrediens:

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

Tilgjengelig fra:

Proficient Rx LP

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

For temporary relief of pain

Autorisasjon status:

OTC monograph not final

Preparatomtale

                                LIDOZEN- LIDOCAINE HYDROCHLORIDE, MENTHOL PATCH
PROFICIENT RX LP
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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LIDOZEN PATCH
DRUG FACTS:
ACTIVE INGREDIENTS:
Lidocaine HCL 4.00%
Menthol 1.00%
Toplcal Anesthetic
External Analgesic
USES:
For temporary relief of pain
WARNINGS:
•
•
•
DO NOT USE
in large quantities, particularly over raw surfaces or blistered
areas.
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):
Clean and dry affected area.
Remove patch from backing and apply to affected area.
Use only one patch at a time, and maximum of four patches / day.
Leave patch on affected area for up to 8 hours.
Do not use patches for longer than five consective days.
Children under 12 should consult physician prior to use.
For external use only.
Avoid contact with eyes.
If condition worsens, or if symptoms persist for more than 7 days or
clear up and occur again
within a few days, discontinue use of this product and consult a
physician.
INACTIVE INGREDIENTS:
Propylene Glycol, Carboxymethyl Cellulose Sodium, Dihydroxyaluminum
Aminoacetate, Ethanol,
Glycerin, Kaolin, Partially Neutralized Polyacrylate, Polysorbate 80,
Polyvinylpyrrolidone 90, Tartaric
Acid, Tetrasodium Edetate, Titanium Dioxide, Hydrogenated Castor Oil,
Phenoxyethanol, Urea, Water.
Store below 25 degrees Celsius. Avoid directed sunlight.
PACKAGE LABELING:
LIDOZEN
lidocaine hydrochloride, menthol patch
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7120 5-30 2(NDC:71574-8 0 0 )
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDOCAINE -
UNII:9 8 PI20 0 9 8 7)
LIDOCAINE
40 mg i
                                
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