Label: RITUAL TATTOO- lidocaine, tetracaine lotion

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated February 1, 2022

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  • 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

    • For external use only.
    • Check with client for history of allergic reactions to topical analgesics.
  • 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.
    • If swallowed, get medical help or contact Poison Control Center. 1-800-222-1222
  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Directions

    • Apply lotion generously, then rub into skin until fully absorbed. For best results apply a thick second layer then wrap and let sit for 30-45 minutes before tattooing.
    • Also apply during breaks as needed for sensitive areas.
  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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