83871-001

83871-001
SPL v1
SPL
SPL Set ID 0cd8045e-6562-2ca7-e063-6394a90a54d7
Route
TOPICAL
Published
Effective Date 2023-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Isopropyl Palmitate Alpha-tocopherol Acetate Ginger Cetyl Alcohol Macropiper Methysticum Root Glycerin Water Sunflower Oil Pentylene Glycol Panthenol Menthol Glyceryl Monostearate Aloe Vera Leaf Polyoxyl 100 Stearate Commiphora Myrrha Whole Camphor (natural) Camellia Japonica Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-18

Description

Lidocaine 5%

Purpose

For the temporary relief of local itching, soreness and burning of tattoos, piercing and waxing.


Medication Information

Purpose

For the temporary relief of local itching, soreness and burning of tattoos, piercing and waxing.

Description

Lidocaine 5%

Use

Tattoo Numbing Cream for tattoos, piercing and waxing, provides deep numbness for up to 7 hours of relief itching, soreness and burning of them.

Stop Use

Condition worsens or does not improve within 7 days.

Allergic reaction occurs to ingredients in this product.

Symptom being treated does not subside or if redness, irritation.

Warnings

For external use only.

Keep out of reach of children.

If swallowed, get medical help.

Do not use if allergic to any ingredients.

If pregnant or breastfeeding ask a health professional before use.

Ask Doctor

Swelling, pain or other symptoms develop or increase.

Symptoms clear up and return within a few days.

Directions

1.Cleanse targeted skin area, pat dry.

2.Apply a thick layer (1mm) onto targeted skin area.

3.Wrap the treated area tightly with plastic wrap and remain for 60 minutes for peak numbing. Conduct a patch test to assess your best numbing timing.

4.Remove the plastic wrap and wipe away residue, then begin treatment.

Do Not Use

Allergic reaction occurs to ingredients in this product.

When Using

Do not get into the eyes.

Do not exceed recommended dosage unless directed by a doctor.

Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Active Ingredient

Lidocaine 5%

Other Information

Store in a cool, dry place away from direct sunlight.

Inactive Ingredients

Aqua, Glycerin, Isopropyl Palmitate, Aloe Barbadensis Leaf Extract,

Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Stearate,

Pentylene Glycol, Cetyl Alcohol, Piper Methysticum Leaf/Root/Stem Extract, Peg-100 Stearate, Tocopheryl Acetate, Panthenol, Camellia Japonica Flower Extract,

Zingiber Officinale (Ginger) Root Extract, Commiphora Myrrha Extract, Camphor, Menthol, Lecithin, Phenoxyethanol.

Principal Display Panel

Keep Oot of Reach of Children

If swallowed, get medical help or contact a poison control center right away.


Structured Label Content

Use

Tattoo Numbing Cream for tattoos, piercing and waxing, provides deep numbness for up to 7 hours of relief itching, soreness and burning of them.

Purpose

For the temporary relief of local itching, soreness and burning of tattoos, piercing and waxing.

Stop Use

Condition worsens or does not improve within 7 days.

Allergic reaction occurs to ingredients in this product.

Symptom being treated does not subside or if redness, irritation.

Warnings

For external use only.

Keep out of reach of children.

If swallowed, get medical help.

Do not use if allergic to any ingredients.

If pregnant or breastfeeding ask a health professional before use.

Ask Doctor

Swelling, pain or other symptoms develop or increase.

Symptoms clear up and return within a few days.

Directions

1.Cleanse targeted skin area, pat dry.

2.Apply a thick layer (1mm) onto targeted skin area.

3.Wrap the treated area tightly with plastic wrap and remain for 60 minutes for peak numbing. Conduct a patch test to assess your best numbing timing.

4.Remove the plastic wrap and wipe away residue, then begin treatment.

Do Not Use (Do not use)

Allergic reaction occurs to ingredients in this product.

When Using

Do not get into the eyes.

Do not exceed recommended dosage unless directed by a doctor.

Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Active Ingredient

Lidocaine 5%

Other Information (Other information)

Store in a cool, dry place away from direct sunlight.

Inactive Ingredients (Inactive ingredients)

Aqua, Glycerin, Isopropyl Palmitate, Aloe Barbadensis Leaf Extract,

Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Stearate,

Pentylene Glycol, Cetyl Alcohol, Piper Methysticum Leaf/Root/Stem Extract, Peg-100 Stearate, Tocopheryl Acetate, Panthenol, Camellia Japonica Flower Extract,

Zingiber Officinale (Ginger) Root Extract, Commiphora Myrrha Extract, Camphor, Menthol, Lecithin, Phenoxyethanol.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

If swallowed, get medical help or contact a poison control center right away.


Advanced Ingredient Data


Raw Label Data

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