Country: United States
Language: English
Source: NLM (National Library of Medicine)
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
PLUM VALLEY PHARMA LLC
TOPICAL
OTC DRUG
Purpose: Topical Anesthetic Uses: For the temporary relief of pain Do not use: - More than 1 patch on your body at a time or on cut, iritated or swollen skin. - On puncture wounds - For more than 1 week without consulting a doctor Stop use and ask a doctor if: - Condition worsens - Redness is present - Irritation developes - 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.
OTC monograph not final
LIDOMET-10 KIT- LIDOCAINE/MENTHOL PATCH PLUM VALLEY PHARMA 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._ ---------- LIDOMET -10 PATCH KIT _ACTIVE INGREDIENTS:_ Lidocaine HCL 4% Menthol 4% _PURPOSE:_ Topical Anesthetic _USES:_ For the temporary relief of pain _WARNINGS:_ For external use DO NOT USE: More than 1 patch on your body at a time or on cut, iritated or swollen skin. On puncture wounds For more than 1 week without consulting a doctor WHEN USING THIS PRODUCT: Use only as directed. Read and follow all directions and warnings on this label. Rare cases of serious burns have been reported with products of this type. Do not apply to wounds or damaged, broken or irritated skin. Do not allow contact with the eyes and mucous membranes. 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 and 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 developes 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 CARE 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 the affected area. Open pouch and remove one patch. Remove the protective film from the patch and apply patch to the affected area. Reseal pouch containing unused patches after each use. Use 1 patch for up to 12 hours. CHILDREN 12 YEARS OR Read the complete document