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 PETS If 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)

Principal Display Panel – 118 mL Can Label

FAST FREEZE LIDOCAINE
lidocaine spray

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/10/2020

Labeler - Natural Essentials, Inc. (947484713)

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

DRUG FACTS