LeedFrost Cream (lidocaine 5%)

Drug Details [pdf]

LEEDFROST CREAM (LIDOCAINE 5%)- lidocaine cream
Koru Pharmaceuticals

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.

----------

LeedFrost Cream (lidocaine 5%)

Lidocaine 5%

Topical anesthetic

Temporarily relieves minor pain.

For External Use Only.

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

use only as directed. Read and follow all directions and warnings on this carton.
do not allow contact with tey eyes
do not bandage or apply local heat (such as heating pads) to the area of use

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

ask a health professional before use.

Adults and children over 12 years

apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period
Children 12 years or younger: ask a doctor

Carbomer 940, Cetanol, Glycerin, Clyceryl Monostearate, Isopropyl Myristate, Light Liquid Paraffin, Methylparaben, Polysorbate 60, Porpylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum

1234

LEEDFROST CREAM (LIDOCAINE 5%)
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80393-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
STEARIC ACID (UNII: 4ELV7Z65AP)
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 80393-100-02	1 in 1 BOX	10/16/2020
1	NDC: 80393-100-01	50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/16/2020	12/31/2020

Labeler - Koru Pharmaceuticals (694788172)

Revised: 10/2021

Document Id: cf59e64c-7747-e3fe-e053-2a95a90a8640

Set id: b1b700e3-b320-7809-e053-2995a90a365b

Version: 2

Effective Time: 20211021

LeedFrost Cream (lidocaine 5%)

LeedFrost Cream (lidocaine 5%) by

Drug Labeling and Warnings

Drug Details [pdf]

LeedFrost Cream (lidocaine 5%)