LIDOCAINE- lidocaine spray spray

LIDOCAINE by

Drug Labeling and Warnings

LIDOCAINE by is a Otc medication manufactured, distributed, or labeled by Sichuan Gumo Brand Management Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83365-002
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83365-002-01	141 g in 1 BOX; Type 0: Not a Combination Product	03/25/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/25/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
Sichuan Gumo Brand Management Co.,Ltd		406945503	manufacture(83365-002)