Oheal Tattoo Numbing Cream by Dr.luke Healthcare LLC 83176-012 Completed

Drug Details [pdf]

OHEAL TATTOO NUMBING CREAM- tattoo numbing cream cream
Dr.luke Healthcare LLC

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83176-012 Completed

Active Ingredient

Lidocaine 4%

Purpose

External Analgesic

Use

For temporary relief of local and anorectal discomfort associated with anorectal discomfort or inflammation

Warnings

For External Use Only
Pregnant or breastfeeding, ask a health professional before use.
In case of accidental overdose, contact a doctor or Poison Control Center immediately.
Seal is broken or missing.

Do not use

Pregnant or breastfeeding, ask a health professional before use.
In case of accidental overdose, contact a doctor or Poison Control Center immediately.
Seal is broken or missing.

When Using

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 fingers or any medical device or applicator.

Stop Use

The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Ask Doctor

The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Keep Oot Of Reach Of Children

In case of accidental ingestion, seek medical attention immediately.

Directions

Perform a patch test on the back of your hand before using it to check for skin sensitivity.When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
Apply up to 2 times a day.（Children under 12 years of age: consult a doctor.)

Other information

Keep away from direct sunlight or heat
Store in room temperature (59-860F / 15-300C)

Inactive ingredients

Glycerin, Butylene Glycol, Xanthan Gum, Sodium Hyaluronate, Butyrospermum Parkii (Shea Butter) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Dimethicone, Glyceryl Stearate, Cetearyl Glucoside, Cetearyl Alcohol, Tocopherol, Menthol, Borneol

Questions

www.ohealpro.com

Info@ohealpro.com
669-588-4076

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

OHEAL TATTOO NUMBING CREAM
tattoo numbing cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83176-012
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SHEA BUTTER (UNII: K49155WL9Y)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
TETRACAINE (UNII: 0619F35CGV)
PROCAINE (UNII: 4Z8Y51M438)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BORNEOL (UNII: M89NIB437X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)
CENTELLA ASIATICA ROOT (UNII: 8MXU1P42J0)
PRILOCAINE (UNII: 046O35D44R)
RICE GERM (UNII: 7N2B70SFEZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
JOJOBA OIL (UNII: 724GKU717M)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 83176-012-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	06/29/2023	11/21/2024

Labeler - Dr.luke Healthcare LLC (118868014)

Name	Address	ID/FEI	Business Operations
Establishment
Dr.luke Healthcare LLC		118868014	label(83176-012) , manufacture(83176-012)

Revised: 11/2024

Document Id: 2764ac5e-c63b-4e28-e063-6394a90a9c40

Set id: ff52921a-8dba-0613-e053-6294a90ae7fd

Version: 2

Effective Time: 20241120