RITUAL TATTOO- lidocaine, tetracaine lotion 
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 Lotion

Active Ingredients

Lidocaine 4% w/v. Purpose: Topical analgesic

Tetracaine 1% w/v. Purpose: Topical analgesic

Purpose

Lidocaine 4% w/v. Purpose: Topical analgesic

Tetracaine 1% w/v. Purpose: Topical analgesic

Uses

For temporary relief of pain during tattoo and piercing procedures.

Warnings

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

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

Keep out of reach of children

Directions

Other Information or Comments

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

Inactive Ingredients

Aloe vera leaf juice powder, Apricot kernel oil, Benzoic acid, Cetearyl alcohol, Citric acid, Coco-glucoside, Coconut oil, Dehydroacetic acid, Lactic acid, Phenoxyethanol, Purified water, Shea butter, Sunflower seed oil, Tocopherol, Xanthan gum

Principal Display Panel

60 mL NDC: 82171-001-60

Lotion Label

RITUAL TATTOO 
lidocaine, tetracaine lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82171-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV) TETRACAINE1 g  in 100 mL
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TOCOPHEROL (UNII: R0ZB2556P8)  
LACTIC ACID (UNII: 33X04XA5AT)  
APRICOT KERNEL OIL (UNII: 54JB35T06A)  
WATER (UNII: 059QF0KO0R)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCO GLUCOSIDE (UNII: ICS790225B)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SHEA BUTTER (UNII: K49155WL9Y)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82171-001-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/31/2021
Labeler - MK Laboratory (118238452)
Establishment
NameAddressID/FEIBusiness Operations
MK Laboratory118238452manufacture(82171-001)

Revised: 2/2022
Document Id: d6f1bfb4-dd83-63b7-e053-2995a90a2a78
Set id: cae221d5-6380-7742-e053-2a95a90abc0b
Version: 2
Effective Time: 20220201
 
MK Laboratory