Label: LIDOTHAL RELIEF- menthol, lidocaine patch
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Contains inactivated NDC Code(s)
NDC Code(s): 71437-463-15 - Packager: 19 And Pacific, Llc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 31, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings:
- For external use only
- Avoid contact with eyes
- Do not apply to open wounds or damages skin
- If symptoms persist for more than seven days, discontinue use and consult physician
- Keep out of reach of children. If swallowed, consult physician.
- Do not bandage tightly
- If pregnant or breast feeding, contact physician prior to use
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions:
- Clean and dry affected area
- Remove patch from backing and apply to affected area. Apply directly to affected area.
- Use only on patch at a time, and a maximum of four patches per day.
- Leave patch of affected area for up to eight hours.
- Do not use patches for more than five consecutive days
- Children under 12 should consult a physician prior to use.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIDOTHAL RELIEF
menthol, lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71437-463 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g Inactive Ingredients Ingredient Name Strength ACRYLIC ACID (UNII: J94PBK7X8S) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYL ACRYLATE (UNII: WC487PR91H) NONOXYNOL-30 (UNII: JJX07DG188) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TALC (UNII: 7SEV7J4R1U) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71437-463-15 15 in 1 BOX 07/31/2017 1 8.5 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/31/2017 Labeler - 19 And Pacific, Llc (080619263) Establishment Name Address ID/FEI Business Operations 19 And Pacific, Llc 080619263 label(71437-463) , pack(71437-463)
