Bed Bug Instant Bite Relief Gel

Bed Bug Instant Bite Relief Gel
SPL v4
SPL
SPL Set ID 7f472fd0-5605-4cc6-b4b2-1267e815255c
Route
TOPICAL
Published
Effective Date 2016-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Aloe Vera Leaf Calendula Officinalis Flower Green Tea Leaf Carboxypolymethylene Chamomile Diazolidinyl Urea Edetate Disodium Glycerin Menthol Methylparaben Propylene Glycol Propylparaben Water Comfrey Leaf Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-02-04

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

Uses:

For the temporary relief of discomfort and pain associated with • minor burns and skin irritations • minor cuts and scrapes • itching.

Warnings:

For external use only. Avoid contact with the eyes.

Do Not Use

in large quantities, particularly over raw or blistered areas.

Drug Facts

Directions:

Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily.

Package Labeling:

Active Ingredients

Lidocaine 4%

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine

Stop Use and Ask A Doctor If

•skin becomes irritated • condition worsens or sysmptoms last than 7 days • symptoms clear up and recur within a few days.


Structured Label Content

Uses:

For the temporary relief of discomfort and pain associated with • minor burns and skin irritations • minor cuts and scrapes • itching.

Purpose

Topical Anesthetic

Warnings:

For external use only. Avoid contact with the eyes.

Do Not Use (Do not use)

in large quantities, particularly over raw or blistered areas.

Drug Facts

Directions:

Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily.

Package Labeling:

Active Ingredients

Lidocaine 4%

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

•skin becomes irritated • condition worsens or sysmptoms last than 7 days • symptoms clear up and recur within a few days.


Advanced Ingredient Data


Raw Label Data

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