Zims lido freeze gel

Spl unclassified section

Drug Facts

Active ingredients

Lidocaine 4%

Menthol USP 1 %

Purpose

Topical Analgesic

Topical Analgesic

Use

  • For the temporary relief of pain.

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

Otc - pregnancy or breast feeding section

If pregnant or breast feedingask a physician before use.

Otc - keep out of reach of children section

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

  • Apply to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
  • After applying, wash hands with soap and water
  • Under age 12, consult a physician before use

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.

Ingredients and appearance - Product information

Zims lido freeze gel- Menthol, unspecified form and lidocaine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 66902-230
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Menthol, unspecified form ( UNII: L7T10EIP3A)( Menthol - UNII: L7T10EIP3A ) 10 mgin 1 mL
Lidocaine ( UNII: 98PI200987)( Lidocaine - UNII: 98PI200987 ) 40 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
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)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part348 USA

Labeler - NATURAL ESSENTIALS, INC( 947484713)

Establishment

Name ID/FEI Business Operations
NATURAL ESSENTIALS, INC 947484713 MANUFACTURE( 66902-230)

Package label.principal display panel

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)