LIDOCAINE by Sichuan Gumo Brand Management Co.,Ltd 83365-001

Drug Details [pdf]

LIDOCAINE- lidocaine spray spray
Sichuan Gumo Brand Management Co.,Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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83365-001

Active Ingredient

Lidocaine Hcl 5%

Phenylephrine Hcl 0.25%

Purpose

Local Anesthetic

Vasoconstrictor

Uses

For the temporary relief of local and anorectal itching , discomfortand pain associated with anorectal disorder or anorectal inflammation.

Warnings

Do not use this product if :
pregnant or breastfeeding, ask a health professional before use.
tamper-evident " Do not se this product if seal is broken or missing.
you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor.

Do not use

When using

When using this product
do not exceed the recommended the daily usage.
certain persons can develop allergic reactions to ingredients in this product.
do nut put this product into the rectum by using finger or any medical device or applicator.
If swallowed, call your Poison Control Center immediately. If condition worsens or does not improve within 7 days, consult a doctor

Stop use

Stop use and ask a doctor if
The symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Directions

Cleanse the affected area.
Sensitivity and possible allergy tests advised prior to use Spray sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs . You may reapply to continue numbing effect.
apply to the affected area up to 4 times daily.
children under 12 years of age: consult a doctor.

Other Information

Keep away from direct sunlight or heat.
store in room temperature (59-86F/15-30C)

Inactive Ingredients

Allantoin, Arginline, Benzyl Alcohol, Disodium EDTA , Ethoxydiglycol, Phenoxyethanol, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Sulfite

Keep Out Of

Keep Out Of Reach Of Children If Swallowed .Get Medical Help Or Contact A Poison Control Center Right Away

83365-001-01

LIDOCAINE
lidocaine spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83365-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 g in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
WATER (UNII: 059QF0KO0R)
SODIUM SULFITE (UNII: VTK01UQK3G)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ARGININE (UNII: 94ZLA3W45F)
ALLANTOIN (UNII: 344S277G0Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 83365-001-01	141 g in 1 BOX; Type 0: Not a Combination Product	03/25/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/25/2023

Labeler - Sichuan Gumo Brand Management Co.,Ltd (406945503)

Name	Address	ID/FEI	Business Operations
Establishment
Sichuan Gumo Brand Management Co.,Ltd		406945503	manufacture(83365-001)

Revised: 3/2023

Document Id: f7b0ce76-8408-6d28-e053-6394a90a3d43

Set id: f7b0ce76-8407-6d28-e053-6394a90a3d43

Version: 1

Effective Time: 20230324