FAST FREEZE LIDOCAINE ROLL-ON- lidocaine hydrochloride, benzyl alcohol liquid 
Natural Essentials, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

OTHER INFORMATION

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

3 oz (89 mL)

Principal Display Panel – 89 mL Container Label
FAST FREEZE LIDOCAINE ROLL-ON 
lidocaine hydrochloride, benzyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-235
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous40 mg  in 1 mL
Benzyl Alcohol (UNII: LKG8494WBH) (Benzyl Alcohol - UNII:LKG8494WBH) Benzyl Alcohol10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66902-235-0389 mL in 1 CONTAINER; Type 0: Not a Combination Product07/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/10/2020
Labeler - Natural Essentials, Inc. (947484713)
Establishment
NameAddressID/FEIBusiness Operations
NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-235)

Revised: 7/2020
Document Id: 078ec311-0ee4-4e73-a1e9-e1ad2268d151
Set id: 74b06366-5eb4-4eba-aa2b-2b672828294d
Version: 1
Effective Time: 20200710
 
Natural Essentials, Inc.