PARCHE LEON MILAGROSO- capsaicin, camphor, menthol patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM), CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

Pharmadel LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Capsicum oleoresin 0.025%..................................... Camphor 3%............................................................. Menthol 1.25%.......................................................... For temporary relief of minor aches and pains of muscles and joints associated with - simple backache - arthritis - strains - sprains

Authorization status:

OTC monograph not final

Summary of Product characteristics

PARCHE LEON MILAGROSO- CAPSAICIN, CAMPHOR, 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._
----------
PARCHE LEON MILAGROSO HOT
DRUG FACTS
ACTIVE INGREDIENTS & PURPOSE
_ACTIVE INGREDIENTS (IN EACH PATCH)_
_PURPOSE_
Capsicum oleoresin 0.025%.....................................
External analgesic
Camphor
3%.............................................................
External analgesic
Menthol
1.25%..........................................................
External analgesic
_USES_
For temporary relief of minor aches and pains of muscles and joints
associated with
simple backache
arthritis
strains
sprains
_WARNINGS_
FOR EXTERNAL USE ONLY. Avoid contact with the eyes.
KEEP OUT OF REACH OF CHILDREN
In case accidental ingestion, get medical help or contact a poision
Control Center right away.
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms persist for more than 7 days
clear up and occur again within a few days
redness is present
DO NOT USE
on wounds or damaged skin
sensitive skin
if you are allergic to any ingredients of this product
If pregnant or breast-feeding,
ask a health professional before use.
_DIRECTIONS_
ADULTS & CHILDREN 12 YEARS OF AGE AND OLDER: apply to affected area
not more than 3 to 4 times daily
CHILDREN UNDER 2 YEARS OF AGE: consult a doctor
clean and 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 FEATURE: Do not use if packet containing the patch is
torn or broken.
_INACTIVE INGEDIENTS_
distearyl pentaerythritol diphosphite, glyceryl rosinate, light
mineral oil, styrene block copolymers
_QUESTIONS OR COMMENTS?_
1-899-359-3478 (M-F) 9 AM to 5 PM Easte