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Point Relief LidoSpot

Dosage form: patch
Ingredients: LIDOCAINE HYDROCHLORIDE 4g in 100g, MENTHOL, UNSPECIFIED FORM 1g in 100g
Labeler: Fabrication Enterprises
NDC Code: 51452-727

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.

Point Relief LidoSpot ​™​ Patch

Drug Facts

Lidocaine HCl 4%

Menthol 1%

Topical Anesthetic

External Anesthetic

USES

For temporary relief of pain and itching associated with minor burns, cuts, scrapes and minor skin irritations.

WARNINGS
  • For External use only. Use only as directed.
  • Avoid contact with eyes and mucous membranes.
  • If symptoms persist for more than 7 days, discontinue use and consult a physician
  • If swallowed, consult a physician.

  • Keep out of reach of children. Consult a physician prior to using on children under 12.

  • Do not apply to open wounds or damaged skin.
  • Do not use oils, lotions or powders on treatment area prior to application.
  • Do not use with any bandage, wrap, stocking or similar device or garment.

  • If pregnant or breast feeding, contact a physician prior to use.

DIRECTIONS
  • Apply to treatment area.
  • How to apply:
  • Clean and dry treatment area.
  • If customized size is needed, cut patch to the desired size/shape with scissors.
  • Remove protective backing from patch to expose active ingredient and adhesive.
  • Apply patch to treatment area.
  • Use only one patch at a time. Use a maximum of four patches per day.
  • Leave patch on treatment area for up to 12 hours.
  • Do not use patches for longer than 5 consecutive days.

OTHER INGREDIENTS

Water, Glycerol, Sodium polyacrylate, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Camellia Sinensis (Green Tea) Extract, Aluminiumglycinate, Titaniumdioxide, Kaolin, Tween 80, Propylene glycol, Tartaric acid, PVP, Polyacrylic acid, Methylparaben, Propylparaben.

Store at room temperature

Avoid direct sunlight

Representative Labeling

POINT RELIEF LIDOSPOT 
lidocaine hcl, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-727
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
MENTHOL, UNSPECIFIED FORM (MENTHOL) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
WATER 
ARNICA MONTANA FLOWER 
INDIAN FRANKINCENSE 
GREEN TEA LEAF 
METHYLPARABEN 
POLYACRYLIC ACID (250000 MW) 
GLYCERIN 
POVIDONE, UNSPECIFIED 
TARTARIC ACID 
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) 
POLYSORBATE 80 
KAOLIN 
TITANIUM DIOXIDE 
SODIUM POLYACRYLATE (2500000 MW) 
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:51452-727-015 PATCH in 1 POUCH
18 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/02/2016
Labeler - Fabrication Enterprises (070577218)

Revised: 12/2017
 
Fabrication Enterprises

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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