Label: MAXIMUM STRENGHT LIDOCAINE PLUS MENTHOL PAIN RELIEF PATCH- lidocaine, menthol patch
- NDC Code(s): 11822-6514-1
- Packager: Rite Aid Corporation
- 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.
Updated April 15, 2021
If you are a consumer or patient please visit this version.
- Active Ingredients
- Do not Use
When using this product
■ use only as directed
■ read and follow all directions and warnings on this carton
■ do not allow contact with the eyes
■ do not use at the same time as other topical analgesics
■ do not bandage tightly or apply local heat (such as heating pads) to the area of use
■ do not microwave
■ 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 consult a doctor
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children and pets.
Dosage and Administration
Directions Adults and children 12 years of age and over :
■ Clean and dry affected area
■ Carefully remove backing from patch starting at a corner.
■ Apply sticky side of patch to affected area.
■ use one patch for up to 12 hours.
■ Discard patch after single use.
■Children under 12 years of age: consult a physician.
- Other Safety Information
- Inactive Ingredients
- Maximum Strenght Lidocaine plus Menthol Pain Relief Patch
INGREDIENTS AND APPEARANCE
MAXIMUM STRENGHT LIDOCAINE PLUS MENTHOL PAIN RELIEF PATCH
lidocaine, menthol patch
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-6514 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 1 g in 100 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) Product Characteristics Color Score Shape RECTANGLE Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-6514-1 5 in 1 CARTON 03/01/2021 1 1 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 03/01/2021 Labeler - Rite Aid Corporation (014578892) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech 529128763 manufacture(11822-6514)