Inkcouture Tattoo Numbing .Spray by Stellans Inc. 83565-006 Completed

Inkcouture Tattoo Numbing .Spray by

Drug Labeling and Warnings

Inkcouture Tattoo Numbing .Spray by is a Otc medication manufactured, distributed, or labeled by Stellans Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INKCOUTURE TATTOO NUMBING .SPRAY- tattoo numbing spray liquid 
Stellans Inc.

----------

83565-006 Completed

Active Ingredient

Lidocaine 4%

Purpose

External Analgesic

Use

For temporary relief of local discomfort,itching, pain, soreness, or burning in the perianal area associated with anorectal disorders.

Warnings

WARNINGS (FOR EXTERNAL USEONLY)
DO NOT USE THIS PRODUCT IF
*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

IF 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

1.Before the spray's application, wash hands thoroughly and wear disposable tattoo gloves.
2.Clean the area of the body receiving the tattoo . Dry completely.
3. Apply a thick amount of numbing spray to the cleaned area and rub in thoroughly.Cover with plastic wrap.
4. Leave spray and wrap in place for 30-45minutes. Wipe the spray away and clean the area thoroughly and ready for your pain free tattoo.

Other information

STORAGE
*Store at cool and dry room
temperature.

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.Getearyl
Alcohol, Tocopherol,
Menthol.Borneol

Questions

inkcouturestore.com

info@inkcouturestore.com
951-265-8930

PRINCIPAL DISPLAY PANEL

INKCOUTURE TATTOO NUMBING .SPRAY 
tattoo numbing spray liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83565-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
JOJOBA OIL (UNII: 724GKU717M)
DIMETHICONE (UNII: 92RU3N3Y1O)
MENTHOL (UNII: L7T10EIP3A)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
XANTHAN GUM (UNII: TTV12P4NEE)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SQUALANE (UNII: GW89575KF9)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BORNEOL (UNII: M89NIB437X)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83565-006-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/01/2023	09/09/2024

Labeler - Stellans Inc. (111157321)

Establishment
Name	Address	ID/FEI	Business Operations
Stellans Inc.		111157321	label(83565-006) , manufacture(83565-006)

Revised: 9/2024

Document Id: 21ad02fc-eb89-d2ad-e063-6294a90aae29

34390-5

Set id: 09235f26-2260-6ca2-e063-6394a90ad8f1

Version: 2

Effective Time: 20240909