FAST FREEZE LIDOCAINE ROLL-ON- lidocaine hydrochloride, benzyl alcohol liquid

Fast Freeze Lidocaine Roll-On by

Drug Labeling and Warnings

Fast Freeze Lidocaine Roll-On 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]

SPL UNCLASSIFIED SECTION

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

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

• 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)

INGREDIENTS AND APPEARANCE

FAST FREEZE LIDOCAINE ROLL-ON 
lidocaine hydrochloride, benzyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-235
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg  in 1 mL
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH)	BENZYL ALCOHOL	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-235-03	89 mL in 1 CONTAINER; 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(66902-235)