HOT COLD LIDOCAINE WITH MENTHOL- lidocaine, menthol patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Foshan Aqua Gel Biotech Co., Ltd.,

INN (International Name):

LIDOCAINE

Composition:

LIDOCAINE 40 mg

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Anesthetic/ Analgesic Temporarily relieves minor pain - more than 1 patch on your body at a time or on cut, irritated or swollen skin - on puncture wounds - for more than one week without consulting a doctor - condition worsens - redness is present - irritation develops - symptoms persist for more than 7 days or clear up and occur again within a few days - you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Authorization status:

OTC monograph not final

Summary of Product characteristics

HOT COLD LIDOCAINE WITH MENTHOL- LIDOCAINE, MENTHOL PATCH
FOSHAN AQUA GEL BIOTECH CO., LTD.,
_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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HOT COLD LIDOCAINE WITH MENTHOL PATCH
UNDEFINED
Lidocaine 4%
Menthol 1%
PURPOS E
Topical Anesthetic/ Analgesic
US ES
Temporarily relieves minor pain
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
more than 1 patch on your body at a time or on cut, irritated or
swollen skin
on puncture wounds
for more than one week without consulting a doctor
WHEN USING THIS PRODUCT
use only as directed. Read and follow all directions and warnings on
this label.
do not allow contact with the eyes
do not bandage tightly or apply local heat (such as heating pads) to
the area of use
do not use at the same time as other topical analgesics
dispose of used patch in manner that always keeps product away from
children or pets. Used patches
still contain the drug product that can produce serious adverse
effects if a child or pet chews or
ingests this patch.
STOP USE AND ASK A DOCTOR IF
condition worsens
redness is present
irritation develops
symptoms persist for more than 7 days or clear up and occur again
within a few days
you experience signs of skin injury, such as pain, swelling, or
blistering where the product was
applied
IF PREGNANT OR BREAST FEEDING
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN AND PETS
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 backing from patch by firmly grasping both ends and gently
pulling until backing separates in
middle
carefully remove smaller portion of backing from patch and apply
exposed portion of patch to
affected area
once exposed portion of patch is positioned, carefully remove
remaining backing to completely
apply patch to affected area
use 1 patch for up to 12 h