FDA Label for Fast Freeze Lidocaine

View Indications, Usage & Precautions

Fast Freeze Lidocaine Product Label

The following document was submitted to the FDA by the labeler of this product Natural Essentials, 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 Ingredients



Lidocaine 4%


Purpose



Topical Anesthetic


Uses



Temporary relief of minor pain


Warnings



For external use only


Do Not Use



  • In large quantities, particularly over raw surfaces or blistered areas

When Using This Product



  • Keep out of eyes
  • Use only as directed
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F

Stop Use And Ask A Doctor If



  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding



IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN AND PETS If swallowed, get medical help or contact a Poison Control Center right away


Directions



Shake well

  • Adults and children over 12 years:
  • Apply a thin layer to affected area not more than 3 to 4 times daily

    • To apply to face, spray into palm of hand and gently apply
    • Children under 12 years of age, ask a doctor

Inactive Ingredients



Acrylates/C10-30 Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Deionized Water, Diazolidinyl Urea. Dimethicone, Disodium Cocamphodipropionate. Disodium EDTA, Glycerin. Propylene Glycol, SDA 39C Alcohol, Tocopheryl Acetate, Triethanolamine.


Principal Display Panel – 118 Ml Can Label



FAST FREEZE®

MAXIMUM STRENGTH
LIDOCAINE
CONTINUOUS SPRAY

UNSCENTED

  • Numbing relief
  • No mess, greaseless & stain-free
  • Natural ingredients include
    Vitamin E and Aloe
  • For the temporary relief of
    minor aches and pains of muscles
    and joints; associated with backache,
    arthritis, strains and sprains
  • Paraben Free
  • Fast Drying
  • 3 oz (89 mL)


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