Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4b743662-1ac0-4682-86d0-5488e72f3095
Route
TOPICAL
Published
Effective Date 2011-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 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 2011-11-15
Description

Cutiecaine-5%, Topical Lidocaine Cream (5% 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

Warnings and Precautions
•    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.

Indications and Usage
Use for reducing pain or discomfort from;  hemorrhoids pain and Itching. minor cuts, abrasions, minor burns, sun burns, insect bites, poison ivy,  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
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-5%, Topical Lidocaine Cream (5% 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 50565-1
Keep both used and unused medicine out of the reach of children or pets
Section 51727-6
Inactive Ingredients; water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil,SDS, Net Wt. 15g



Section 51945-4
carton.jpg
Section 55105-1
for relief of pain and discomfort from; hemorrhoids pain and Itching, Other Uses; minor cuts, bruises, sun burn, insect bites, poison ivy, etc.
Section 55106-9
Cutiecaine-5%, Topical Lidocaine Cream (5% 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

Indications and Usage (34067-9)
Use for reducing pain or discomfort from;  hemorrhoids pain and Itching. minor cuts, abrasions, minor burns, sun burns, insect bites, poison ivy,  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
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
Warnings and Precautions (34071-1)
•    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 50565-1 (50565-1)
Keep both used and unused medicine out of the reach of children or pets
Section 51727-6 (51727-6)
Inactive Ingredients; water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil,SDS, Net Wt. 15g



Section 51945-4 (51945-4)
carton.jpg
Section 55105-1 (55105-1)
for relief of pain and discomfort from; hemorrhoids pain and Itching, Other Uses; minor cuts, bruises, sun burn, insect bites, poison ivy, etc.
Section 55106-9 (55106-9)
Cutiecaine-5%, Topical Lidocaine Cream (5% 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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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:22.127386 · Updated: 2026-03-14T22:52:54.626056