Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 029bd3fb-1b5b-48e0-b9af-d91d548b5b0f
Route
TOPICAL
Published
Effective Date 2020-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Aloe Vera Leaf Matricaria Chamomilla Flowering Top Cucumber Water Diazolidinyl Urea Dimethicone Disodium Cocoamphodipropionate Edetate Disodium Glycerin Propylene Glycol Alcohol .alpha.-tocopherol Acetate Trolamine

Identifiers & Packaging

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

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

Uses

Temporary relief of minor pain

Section 50565-1

KEEP OUT OF REACH OF CHILDREN AND PETSIf 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

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
Do Not Use
  • In large quantities, particularly over raw surfaces or blistered areas
Active Ingredients

Lidocaine 4%

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.

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
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)


Structured Label Content

Uses (USES)

Temporary relief of minor pain

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN AND PETSIf 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

Warnings (WARNINGS)

For external use only

Directions (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
Do Not Use (DO NOT USE)
  • In large quantities, particularly over raw surfaces or blistered areas
Active Ingredients (ACTIVE INGREDIENTS)

Lidocaine 4%

Inactive Ingredients (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.

When Using This Product (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 (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
Principal Display Panel – 118 Ml Can Label (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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)