RITUAL TATTOO- lidocaine, tetracaine, witch hazel spray
MK Laboratory

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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Ritual Tattoo Numbing Spray

Active Ingredients

Lidocaine 4%

Tetracaine 1%

Witch Hazel 30%

Purpose

Lidocaine: Topical analgesic

Tetracaine: Topical analgesic

Witch Hazel: Astringent

Uses

For temporary relief of pain during tattoo and piercing procedures.
To reduce inflammation & redness causing less damage to skin during tattooing or piercing procedures. Also used to desensitize the tattoo area for longer tattoo sessions and happier clients.

Warnings

For external use only.
If swallowed, get medical help or contact Poison Control Center. 1-800-222-1222

Do Not Use

DO NOT USE more than 2 oz. in a 6 hour period.

When Using

Avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop Use

Stop use and contact doctor if skin irritations occur. If irritation, rinse thoroughly with water.

Keep out of reach of children.

Directions

Recommended usage is 1-2 sprays per 3 in. x 3 in. area. Reapply as needed.
Best results if you wrap the area and let sit for 10-20 minutes.

Other Information or Comments

For questions or comments please send email to Ritualtattooproducts@gmail.com

Inactive Ingredients

Benzoic acid, Distilled water

Principal Display Panel

60 mL NDC: 82171-002-60

Spray Label

RITUAL TATTOO
lidocaine, tetracaine, witch hazel spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82171-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE	1 g in 100 mL
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	30 g in 100 mL
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82171-002-60	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/01/2021

Labeler - MK Laboratory (118238452)

Name	Address	ID/FEI	Business Operations
Establishment
MK Laboratory		118238452	manufacture(82171-002)

Revised: 9/2021

Document Id: caf0bfd8-2be2-5d6e-e053-2995a90a49a7

Set id: caf0bfd8-2be1-5d6e-e053-2995a90a49a7

Version: 1

Effective Time: 20210901

MK Laboratory