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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

1

OHEAL TATTOO NUMBING CREAM 
tattoo numbing cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83176-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TOCOPHEROL (UNII: R0ZB2556P8)  
RICE GERM (UNII: 7N2B70SFEZ)  
JOJOBA OIL (UNII: 724GKU717M)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83176-012-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01606/29/2023
Labeler - Dr.luke Healthcare LLC (118868014)
Establishment
NameAddressID/FEIBusiness Operations
Dr.luke Healthcare LLC118868014label(83176-012) , manufacture(83176-012)

Revised: 6/2023
Document Id: ff52921a-8dbb-0613-e053-6294a90ae7fd
Set id: ff52921a-8dba-0613-e053-6294a90ae7fd
Version: 1
Effective Time: 20230630
 
Dr.luke Healthcare LLC