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  5. Label Information: Fast Freeze Lidocaine Roll-on

FDA Label for Fast Freeze Lidocaine Roll-on

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL – 89 ML CONTAINER LABEL

Fast Freeze Lidocaine Roll-on 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.

Other



DRUG FACTS


Active Ingredients



Lidocaine HCl 4%

Benzyl Alcohol 10%


Purpose



Topical Anesthetic

Topical Anesthetic


Uses



Temporary relief of minor pain


Warnings



For external use only

FLAMMABLE:Keep away from fire or flame


Do Not Use



  • on wounds or damaged skin
  • in large quantities
  • with a heating pad
  • if you are allergic to any ingredients of this product

When Using This Product



  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly

Stop Use And Ask A Doctor If



  • skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms 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



  • Adults and children 12 years of age and over
  • clean and dry affected area
  • apply to affected area not more than 3 to 4 times daily children 12 years or younger ask a doctor

Other Information



  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store with lid closed tightly

Inactive Ingredients



Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Citric Acid, Deionized Water, SDA 40-B Alcohol, Tromethamine


Principal Display Panel – 89 Ml Container Label



FAST FREEZE®

MAXIMUM STRENGTH
LIDOCAINE
ROLL-ON

UNSCENTED

* Please review the disclaimer below.