PARCHE DE LEON- lidocaine, menthol patch

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Pharmadel LLC

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

For the temporary relief of pain.

Autorisasjon status:

OTC monograph not final

Preparatomtale

PARCHE DE LEON- LIDOCAINE, MENTHOL PATCH
PHARMADEL LLC
_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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PARCHE LEON GEL PATCH (SHANGHAI G)
DRUG FACTS
ACTIVE INGREDIENTS & PURPOSE
_ACTIVE INGREDIENTS (IN EACH PATCH)_
_PURPOSE_
Lidocaine 4% .................
External analgesic
Menthol 1% ....................
External analgesic
USES
For the temporary relief of pain.
_WARNINGS_
FOR EXTERNAL USE ONLY. Avoid contact with the eyes.
DO NOT USE
in large quantities, particularly over raw surfaces or blistered areas
on sensitive skin
if allergic to any ingredients in this product
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms persist for more than 7 days or clear up and occur again
within a few
days
redness is present
IF PREGNANT OF 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 & CHILDREN 12 YEARS OF AGE AND OLDER: apply to affected area
not more
than 3 to 4 times daily
CHILDREN UNDER 12 YEARS OF AGE: consult a doctor
- clean dry affected area
- remove patch from film
- apply sticky side of patch to affected area
- use one patch at a time
- leave patch on affected area for up to 8-hours at a time
_OTHER INFORMATION_
store at room temperature 59-86 F (15-30 C)
do not store in direct sunlight or expose to excessive heat
TAMPER EVIDENT: Do not use if packet containing the patch is torn or
broken.
_INACTIVE INGREDIENTS_
dihydroxyaluminum aminoacetate anhydrous, edetate disodium, glycerin,
hydroxyacetophenone, kaolin, mineral oil, polyacrylic acid,
polysorbate 80, propylene glycol, povidone k90, sodium polyacrylate,
tartaric acid,
titanium dioxide, water
PRINCIPAL DISPLAY PANEL
5 Patches (5.5 in x 3.94 in (13.97 cm x 10 cm) each)
Maximum Strength
Fast Acting pain relief
PARCHE DE LEON
lidocaine, menthol patch
PRODUC