Label: RITUAL TATTOO- lidocaine, tetracaine, witch hazel spray

  • 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%

    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

    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

  • INGREDIENTS AND APPEARANCE
    RITUAL TATTOO 
    lidocaine, tetracaine, witch hazel spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82171-002
    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) LIDOCAINE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82171-002-6060 mL in 1 BOTTLE, SPRAY; 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(82171-002)