LidoStat CREAM

Active Ingredient

Lidocaine HCL 4%

Purpose

External Anesthetic

Uses:

For temporary relief of pain and itching caused by minor skin irritations.

Warnings:

For external use only.

Do not use

on children under 2 years of age unless directed by a physician.

When using this product

avoid contact with eyes Use only as directed. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if:

symptoms persist for more than seven days, or clear up and occur again within a few days.
redness, irritation, swelling, pain or other symptoms increase

Keep out of reach of children.

If swallowed, consult a physician.

Directions:

For adults and children two-years or older, apply externally to the affected area. Do not use more than three to four times per day.

Children under 2 years of age: Ask a doctor.

Other information:

Store at room temperature (68-77ºF) (20º-25ºC)

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bin Vinyl Dimethicone/Dimethicone Copolymer, C13-14 Isoparaffin, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Laureth-7, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Polysorbate-20, Stearic Acid, Triethanolamine, Urea.

Question or Comments?

Please visit www.BakoCTS.com

LidoStatTM Cream

Distributed by: CLINICAL THERAPEUTIC SOLUTIONS A Part of bako's Integrated Physician Solution PO Box 1257, Wall, NJ 07719 732.894.9450 •

www.BakoCTS.com

LidoStat CREAM

Lidocaine HCI 4% In a 20% Urea Vehicle MEDICAL STRENGTH PAIN CREAM

PENETRATING FORMULA

Dipensed Only by Physicians

NET WT. 2.0 oz (56 g)

LOT:

EXP:

LidoStat CREAM 2oz/56g (44577-704-02)

Inner Label Outer Label

LIDOSTAT
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:44577-704
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAURETH-7 (UNII: Z95S6G8201)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
UREA (UNII: 8W8T17847W)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:44577-704-02	1 in 1 CARTON	02/07/2017
1		56 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 Drug	M017	06/19/2013

Labeler - Clinical Therapeutic Solutions (078402750)