FDA Label for Pure-aid

View Indications, Usage & Precautions

Pure-aid Product Label

The following document was submitted to the FDA by the labeler of this product Kareway Product, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Lidocaine 4%

Menthol 1%


Purposes



Topical Anesthetic

Topical Analgesic


Uses



Temporarily relieves minor pain


Warnings



For external use only


Do Not Use



  • more than 1 patch on your body at a time or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one 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 develops
  • 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 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 affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 2 patch for up to 24 hours
  • children 12 years or younger: ask a doctor


Inactive Ingredients



dihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid,

propylene glycol, propylparaben, pvp, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water


Package/Label Principal Display Panel



Pure-Aid

MAXIMUM STRENGTH

LIDOCAINE PATCH
PLUS MENTHOL

Targeted Immediate Pain Relief

  • Desensitizes Aggravated Nerves
  • Dual Action with Lidocaine and Menthol
  • Fast Acting and Long Lasting
  • First Aid for Pain
  • Pain Relieving Ointment
    on a Breathable Adhesive Pad

    Contains 1 Patch

    3-15/16” x 5-1/2” (10 cm x 14 cm) each

    Label


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