SPL v2
SPL
SPL Set ID 74b06366-5eb4-4eba-aa2b-2b672828294d
Route
TOPICAL
Published
Effective Date 2020-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzyl Alcohol (40 mg)
Inactive Ingredients
Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Aloe Vera Leaf Citric Acid Monohydrate Water Alcohol Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-10

Description

DRUG FACTS

Purpose

Topical Anesthetic Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Topical Anesthetic

Description

DRUG FACTS

Uses

Temporary relief of minor pain

Section 42229-5

DRUG FACTS

Section 50565-1

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

Section 53414-9

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

Warnings

For external use only

FLAMMABLE:Keep away from fire or flame

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

Lidocaine HCl 4%

Benzyl Alcohol 10%

Inactive Ingredients

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

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
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)


Structured Label Content

Uses (USES)

Temporary relief of minor pain

Section 42229-5 (42229-5)

DRUG FACTS

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

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

Purpose (PURPOSE)

Topical Anesthetic

Topical Anesthetic

Warnings (WARNINGS)

For external use only

FLAMMABLE:Keep away from fire or flame

Directions (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
Do Not Use (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
Other Information (OTHER INFORMATION)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store with lid closed tightly
Active Ingredients (ACTIVE INGREDIENTS)

Lidocaine HCl 4%

Benzyl Alcohol 10%

Inactive Ingredients (INACTIVE INGREDIENTS)

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

When Using 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 (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
Principal Display Panel – 89 Ml Container Label (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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)