Label: RITUAL TATTOO REVEAL FOAM- lidocaine, tetracaine, witch hazel liquid

  • 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 2% w/v. Purpose: Topical analgesic

    Tetracaine 1% w/v. Purpose: Topical analgesic

    Witch Hazel 30% w/v. Purpose: Astringent

  • Purpose

    Lidocaine 2% w/v. Purpose: Topical analgesic

    Tetracaine 1% w/v. Purpose: Topical analgesic

    Witch Hazel 30% w/v. Purpose: Astringent

  • Uses

    • For temporary relief of pain during tattoo and piercing procedures.
    • Reduce sensitivity, inflammation, and redness during tattoo and piercing aftercare
  • Warnings

    • For external use only.
    • Check with client for history of allergic reactions to topical analgesics.
  • DO NOT USE

    DO NOT USE more than 30 mL 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.
    • If swallowed, get medical help or contact Poison Control Center. 1-800-222-1222
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Directions

    • Pump foam generously, spread over tattoo or piercing and let sit 10-30 seconds before wiping with damp paper towel.
    • For use during breaks and on completed tattoos and piercing. Also great for aftercare uses.
  • Other Information or Comments

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

  • Inactive Ingredients

    Cannabis Sativa Seed Oil (Hempseed Oil), Citric Acid, Coconut Oil, Glycerin, Hydroxide Pellets, Jojoba Oil, Olea Europaea Fruit Oil, Palm Kernel Flakes, Potassium, Tocopheryl Acetate (Vitamin E Oil), Water

  • Principal Display Panel

    250 mL NDC: 82171-003-60

    Foam Label

  • INGREDIENTS AND APPEARANCE
    RITUAL TATTOO REVEAL FOAM 
    lidocaine, tetracaine, witch hazel liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82171-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV) TETRACAINE1 g  in 100 mL
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL30 g  in 100 mL
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PALM KERNEL OIL (UNII: B0S90M0233)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    JOJOBA OIL (UNII: 724GKU717M)  
    WATER (UNII: 059QF0KO0R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82171-003-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2021
    Labeler - MK Laboratory (118238452)
    Establishment
    NameAddressID/FEIBusiness Operations
    MK Laboratory118238452manufacture(82171-003)
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