LIDOZEN PATCH- lidocaine, menthol patch

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Village Pharma LLC

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

OTC DRUG

Ábendingar:

For temporary relief of pain

Leyfisstaða:

OTC monograph not final

Vara einkenni

LIDOZEN PATCH- LIDOCAINE, MENTHOL PATCH
VILLAGE PHARMA LLC
----------
LIDOZEN PATCH
DRUG FACTS:
ACTIVE INGREDIENTS:
Lidocaine 4.00%
Menthol 1.00%
Topical Anesthetic
External Analgesic
USES:
For temporary relief of pain
WARNINGS:
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.
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 consecutive days.
Children under 12 should consult physician prior to use.
INACTIVE INGREDIENTS
Water, Glycerol, Sodium Polyacrylate, Propylene Glycol, Polysorbate
80, Tartaric Acid,
Dihydroxyaluminium Aminoacetate, Methylparaben
STORE BELOW 25 DEGREES CELSIUS. AVOID DIRECT SUNLIGHT.
PACKAGE LABELING:
LIDOZEN PATCH
lidocaine, menthol patch
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:71574-905
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
LIDOCAINE
40 mg in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
MENTHOL
10 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TARTARIC ACID (UNII: W4888I119H)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
METHYLPARABEN (UNII: A2I8C7HI9T)
Village Pharma LLC
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
M