Fast Freeze Lidocaine Roll-on Liquid
FDA Label NDC 66902-235

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natural Essentials, Inc. for the product Fast Freeze Lidocaine Roll-on (NDC 66902-235). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

  • Numbing relief
  • No mess, greaseless & stain-free
  • Natural ingredients include Aloe
  • For the temporary relief of
    minor aches and pains of muscles
    and joints; associated with backache,
    arthritis, strains and sprains
  • Paraben Free
  • Plus 10% Benzyl Alcohol

    • 3 oz (89 mL)

    Principal Display Panel – 89 mL Container Label (Fas05 0000 01)

    Principal Display Panel – 89 mL Container Label (Fas05 0000 01)

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