001

001
SPL v1
SPL
SPL Set ID e32f1a47-9a5b-73de-e053-2995a90a28a4
Route
TOPICAL
Published
Effective Date 2022-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Allantoin Edetate Disodium Anhydrous Hydrogenated Polydecene Type I Lecithin, Soybean Neopentyl Glycol Dicaprylate/dicaprate Trolamine Alpha-tocopherol Trideceth-6 Aloe Vera Leaf Carbomer Homopolymer, Unspecified Type Dimethyl Isosorbide Benzyl Alcohol Cholesterol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-08-08

Description

Lidocaine 5%

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 5%

Uses

for temporary relief of local and anorectal discomfort associated with anorectal disorder or inflammation

Section 50565-1

Keep out of reach of children

Incase of accidental ingestion , seek medical attention immediately

Stop Use

n/a

Warnings

Warnings ( For extemal use only )

Directions

Adults : When practical , cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blottingwith toilet tissue or a soft cloth , before application of this product.

Apply up to 6 times a day,

Children up under 12 years of age: consult a doctor.

Do Not Use

Do not use this product if

pregnant or breastfeeding , ask a health professional before use.

in case of accidental overdose , get medical help or contact the Poison Control Center immediately.

tamper evident " Do not use this product " if seal is broken or missing.

Active Ingredient

Lidocaine 5%

Other Information

keep away from direct sunlight or heata.

store in room temperature ( 59-86 F/15-30 C )

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimenthyl Isosorbide, Disodium EDTA , Hydrogenated Polydece, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Acetate, Trideceth-6, Triethanolamine

When Using This Product

do not exceed the recommended daily dosage unless directed by a doctor.

certain persons can develop allergic reactions to ingredients in this product.

do not put this product into the rectum by using finger or any medical device or applicator.

Package Label Principal Display Panel


Structured Label Content

Uses

for temporary relief of local and anorectal discomfort associated with anorectal disorder or inflammation

Section 50565-1 (50565-1)

Keep out of reach of children

Incase of accidental ingestion , seek medical attention immediately

Purpose

Local Anesthetic

Stop Use (Stop use)

n/a

Warnings

Warnings ( For extemal use only )

Directions

Adults : When practical , cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blottingwith toilet tissue or a soft cloth , before application of this product.

Apply up to 6 times a day,

Children up under 12 years of age: consult a doctor.

Do Not Use (Do not use)

Do not use this product if

pregnant or breastfeeding , ask a health professional before use.

in case of accidental overdose , get medical help or contact the Poison Control Center immediately.

tamper evident " Do not use this product " if seal is broken or missing.

Active Ingredient

Lidocaine 5%

Other Information

keep away from direct sunlight or heata.

store in room temperature ( 59-86 F/15-30 C )

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimenthyl Isosorbide, Disodium EDTA , Hydrogenated Polydece, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Acetate, Trideceth-6, Triethanolamine

When Using This Product (When using this product)

do not exceed the recommended daily dosage unless directed by a doctor.

certain persons can develop allergic reactions to ingredients in this product.

do not put this product into the rectum by using finger or any medical device or applicator.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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