Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e3043645-67fa-4e1b-9a75-b8b908b49756
Route
TOPICAL
Published
Effective Date 2010-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Water Carbomer Homopolymer Type C Glycerin Stearic Acid Sodium Lauryl Sulfate Isopropyl Alcohol Cetyl Alcohol Alcohol Aloe Hyaluronate Sodium Polysorbate 20 Butylene Glycol Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-05-31

Description

Cutiecaine, Topical Lidocaine Cream (4% w/w),Active Ingredient; Lidocaine Hydrochloride 4% (w/w), Inactive Ingredients ; water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil,Innovatech Inc, Net Wt. 15g


Medication Information

Dosage and Administration
Use for reducing pain or discomfort from minor cuts, abrasions, minor burns, sun burns, insect bites, poison ivy, hemorrhoids pain and Itching. Use small amount (1 to 2 gm) of this medication, apply on the skin with gentle massage to numb the skin or relieve pain (do not occlude). Children under 2 years of age, consult your doctor
Description

Cutiecaine, Topical Lidocaine Cream (4% w/w),Active Ingredient; Lidocaine Hydrochloride 4% (w/w), Inactive Ingredients ; water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil,Innovatech Inc, Net Wt. 15g

Section 50570-1
•    Do not use in or near the eyes

•    Do use in large amount particularly over the raw surfaces or blisters

Stop use and Ask Doctors if

•    Allergic reactions occurs

•    Condition worsen and does not improve

•    Symptoms clean up and returns within few day

•    itching, redness, burning , swelling or other symptoms occurs

•    Keep both used and unused medicine out of the reach of children or pets

•    If swallowed get medical attention right away Call your doctor immediately.

Section 51945-4
carton.jpg
Section 55106-9
Cutiecaine, Topical Lidocaine Cream (4% w/w),Active Ingredient; Lidocaine Hydrochloride 4% (w/w), Inactive Ingredients; water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil,Innovatech Inc, Net Wt. 15g

Structured Label Content

Dosage and Administration (34068-7)
Use for reducing pain or discomfort from minor cuts, abrasions, minor burns, sun burns, insect bites, poison ivy, hemorrhoids pain and Itching. Use small amount (1 to 2 gm) of this medication, apply on the skin with gentle massage to numb the skin or relieve pain (do not occlude). Children under 2 years of age, consult your doctor
Section 50570-1 (50570-1)
•    Do not use in or near the eyes

•    Do use in large amount particularly over the raw surfaces or blisters

Stop use and Ask Doctors if

•    Allergic reactions occurs

•    Condition worsen and does not improve

•    Symptoms clean up and returns within few day

•    itching, redness, burning , swelling or other symptoms occurs

•    Keep both used and unused medicine out of the reach of children or pets

•    If swallowed get medical attention right away Call your doctor immediately.

Section 51945-4 (51945-4)
carton.jpg
Section 55106-9 (55106-9)
Cutiecaine, Topical Lidocaine Cream (4% w/w),Active Ingredient; Lidocaine Hydrochloride 4% (w/w), Inactive Ingredients; water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil,Innovatech Inc, Net Wt. 15g

Advanced Ingredient Data


Raw Label Data

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