Country: United States
Language: English
Source: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Alexso, Inc
TOPICAL
OTC DRUG
Topical anesthetic Topical anesthetic Temporarily relieves pain and itching due to: - minor cuts - sunburn - minor scrapes - minor burns - insect bites - minor skin irritations
OTC monograph not final
LIDOCAINE 4 PERCENT AND MENTHOL 1 PERCENT ROLL-ON- LIDOCAINE AND MENTHOL LIQUID 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 AND MENTHOL ROLL-ON LIDOCAINE AND MENTHOL - LIDOCAINE 4% AND MENTHOL 1% ROLL-ON 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% ROLL-ON DRUG FACTS ACTIVE INGREDIENT Lidocaine 4% Menthol 1% PURPOSE Topical anesthetic Topical anesthetic 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 Glycerin, Borneol, Arnica Montana Flower Extract, Polyethylene Glycol (PEG), Frankincense Oil, Boswellia Extract, Methylsulfonylmethane (MSM), Chondroitin Sulfate, Glucosamine Sulfate, W Read the complete document