ZIMS LIDO FREEZE- menthol, unspecified form and lidocaine gel 
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 4%

Menthol USP 1 %

Purpose

Topical Analgesic

Topical Analgesic

Use

Warnings

For external use only

Do not use

  • if you are allergic to any ingredient in this product
  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

Ask a doctor or pharmacist before use if you are

  • using blood thinning medications, steroids or non-steroidal anti-inflammatory drugs (NSAIDS)

When using this product

  • do not use other topical products
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly or apply local heat (such as heating pads) to area of use or with a medicated patch
  • keep away from excessive heat

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling or blistering where product was applied

If pregnant or breast feeding ask a physician before use.

Keep out of reach of children. If put in the mouth, get medical help or contact a poison control center right away.

Directions

Adults/children 12 years and older

Other information

Store at room temperature - do not exceed 86° Fahrenheit, 30° Celsius

Inactive ingredients

Aloe Barbadensis Leaf Extract, Arnica Extract, Camphor, Carbomer, Deionized Water, Disodium EDTA, Glycerine, Isopropyl Alcohol, Propylene Glycol.

Principal Display Panel - 10mg of Menthol and 40 mg of Lidocaine Canister Label

ZIM'S
LIDO-
FREEZE

LIDOCAINE & MENTHOL

PAIN RELIEF

Lidocaine & Menthol
formula in as easy to use
roll-on applicator

Nature Science

89 mL (3 fl oz)

Principal Display Panel - 10mg of Menthol and 40 mg of Lidocaine Canister Label
ZIMS LIDO FREEZE 
menthol, unspecified form and lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-230
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 mL
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALCOHOL (UNII: 3K9958V90M)  
ARNICA MONTANA (UNII: O80TY208ZW)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66902-230-0389 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product08/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2016
Labeler - NATURAL ESSENTIALS, INC (947484713)
Establishment
NameAddressID/FEIBusiness Operations
NATURAL ESSENTIALS, INC947484713MANUFACTURE(66902-230)

Revised: 8/2016
Document Id: 361d0eb2-d22d-43f6-b2b7-248d9f590b70
Set id: 5d405cc2-907b-49dd-a5b6-118dfb370043
Version: 1
Effective Time: 20160801
 
NATURAL ESSENTIALS, INC