LIDOCAINE AND MENTHOL- lidocaine, menthol gel

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:

Alexso, Inc

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Lidocaine 4% ………………………..Topical anesthetic Menthol 1% …………………………Topical analgesic Temporarily relieves pain and itching due to: - minor cuts - sunburn - minor scrapes - minor burns - insect bites - minor skin irritations

Authorization status:

OTC monograph not final

Summary of Product characteristics

LIDOCAINE AND MENTHOL- LIDOCAINE, MENTHOL GEL
ALEXSO, INC
_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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LIDOCAINE AND MENTHOL GEL
LIDOCAINE AND MENTHOL - LIDOCAINE 4% AND MENTHOL 1% GEL
ALEXSO, INC
_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._
----------
LIDOCAINE 4% AND MENTHOL 1% GEL
​DRUG FACTS
ACTIVE INGREDIENT
PURPOSE
Lidocaine 4% ………………………..Topical anesthetic
Menthol 1% …………………………Topical analgesic
USES
Temporarily relieves pain and itching due to:
minor cuts
sunburn
minor scrapes
minor burns
insect bites
minor skin irritations
WARNINGS
​FOR EXTERNAL USE ONLY.
WHEN USING THIS PRODUCT
do not use in or near the eyes
do not use in large quantities, particularly over raw surfaces or
blistered areas
do not apply to wounds or damaged skin
do not bandage
STOP USE AND ASK A DOCTOR IF
allergic reaction occurs
condition worsens or does not improve within 7 days
symptoms clear up and return within a few days
redness, irritation, swelling, pain or other symptoms begin or
increase
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
adults and children 2 years and
older
apply externally to the affected
area up to 3 to 4 times a day
children under 2 years
do not use except under the
advice and supervision of a
physician
OTHER INFORMATION
May be applied under occlusive dressing.
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C
(59-86°F). See USP
Controlled Room Temperature.
INACTIVE INGREDIENTS
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf
(Aloe Vera Gel)
Juice, Aqua (Deionized Water), Arnica Montana Flower Extract,
Boswellia Serrata Extract,
Ethy