ZIMS LIDO FREEZE- menthol, unspecified form and lidocaine gel

ZIMS LIDO FREEZE by

Drug Labeling and Warnings

ZIMS LIDO FREEZE by is a Otc medication manufactured, distributed, or labeled by NATURAL ESSENTIALS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

• 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.

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)

INGREDIENTS AND APPEARANCE

ZIMS LIDO FREEZE 
menthol, unspecified form and lidocaine gel

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 mg  in 1 mL
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-230-03	89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	08/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/01/2016

Labeler - NATURAL ESSENTIALS, INC (947484713)

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