FAST FREEZE LIDOCAINE- lidocaine spray

Fast Freeze Lidocaine by

Drug Labeling and Warnings

Fast Freeze Lidocaine by is a Otc medication manufactured, distributed, or labeled by Natural Essentials, Inc., NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

KEEP OUT OF REACH OF CHILDREN AND PETSIf 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)

INGREDIENTS AND APPEARANCE

FAST FREEZE LIDOCAINE 
lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-225
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
CUCUMBER (UNII: YY7C30VXJT)
WATER (UNII: 059QF0KO0R)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-225-04	118 mL in 1 CAN; Type 0: Not a Combination Product	07/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/10/2020

Labeler - Natural Essentials, Inc. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	manufacture(66902-225)