Country: United States
Language: English
Source: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
BENERX LLC
TOPICAL
OTC DRUG
Do Not Use - On wounds or damaged skin - With a heating pad - On children under 12 year of age - If pregnant or breast feeding Topical Pain Cream Stop use and ask a doctor if: - Condition worsens or symptoms persists for more than 7 days - Excessive skin irritation occurs - Symptoms clear up and occur again within a few days
OTC monograph not final
RX300 TOPICAL PAIN CREAM PAIN CREAM- MENTHOL, LIDOCAINE CREAM BENERX 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._ ---------- BENERX MD RX300 TOPICAL PAIN CREAM OTC ACTIVE Active Ingredients Purpose Menthol 4% Topical Analgesic Lidocaine 4% Topical Anesthetic Do Not Use On wounds or damaged skin With a heating pad On children under 12 year of age If pregnant or breast feeding Topical Pain Cream Warnings: For external use only Avoid contact with eyes and mucous memberanes Do not bandage tightly Stop use and ask a doctor if Condition worsens or symptoms persist for more than 7 days Symptoms clear up and occur again within a few days Excessive skin irritation occurs Stop use and ask a doctor if: Condition worsens or symptoms persists for more than 7 days Excessive skin irritation occurs Symptoms clear up and occur again within a few days Directions Use as directed Adults and children 12 years of age and older, rub a thin layer to affected area 3-4 times daily Children under 12 years of age consult a physician wash hands after applying Water (Aqua, Eau) cetearyl alcohol polysorbate 60 Caprylic/ Capric Triglyceride Glycerin Glyceryl Stearate Peg 100 Stearate Aloe Barbadensis (Aloe) Leaf Juice Phenoxyethanol Triethanolamine Carbomer Panthenol Methylsulfonyl Methane Argania Spinosa Kernel Oil Lavandula Angustifolia (Lavender) Oil Glucosamine hydrocholride Cannabis Sativa Hemp Oil Boswellia Serrate Extract Ethylhexylglycerin Mentha Anensis (Peppermint) Leaf Oil Rosmarinus Officinalis (Rosemary) Leaf Oil Magnesium Sulfate Choline Chloride Camphor Eucalyptus Globulous Leaf Oil Curcuma Longa (Turmeric) Root Extract Questions or Comments www.benerxmd.com Warnings: For external use only Avoid contact with eyes and mucous memberanes Do not bandage tightly RX300 TOPICAL PAIN CREAM PAIN CREAM menthol, lidocaine cream PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG Read the complete document