Skullduggery Pain Relief And Skin Protection For Tattoos
FDA Label NDC 67234-047

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natureplex, Llc for the product Skullduggery Pain Relief And Skin Protection For Tattoos (NDC 67234-047). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, do not use, otc - ask doctor, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

LIDOCAINE 4%

Drug Facts

VITAMIN A&D

Drug Facts

This product
is manufactured
and distributed
by Natureplex™.

Active Ingredient

Lidocaine 4%

Purpose

Pain Reliever

Use

For temporary relief of pain associated with minor skin irritations due to tattooing, piercing, and hair removal

Temporarily protects and helps relieve minor skin irritation due to tattooing, piercing, and hair removal

Warnings

For external use only.

Avoid contact with eyes

For external use only.

Avoid contact with eyes

Do Not Use

  • if you are allergic to any ingredient in lidocaine cream or to similar medicines (for example, local anesthetics such as benzocaine)
  • in large quantities, particulary over raw surfaces or blistered areas

Otc - Ask Doctor

Ask a doctor before use if you have had an allergic reaction (for example, rash, hives, dizziness) to any anesthetic medicine

Stop Use And Ask A Doctor If

  • you develop a persistant rash
  • condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
    • you develop a persistent rash
    • side effects occur, condition worsens, or
    • symptoms persist for more than 7 days
      • condition worsens
      • symptoms last more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away: 800-222-1222.

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away: 800-222-1222.

Directions

  • for adult use only
  • before procedure, apply a small amount of 4% Lidocaine to affected area and allow to dry. Application may be repeated up to 4 times daily.

Other Information

  • see bottom of carton for lot number and expiration date
  • store at 15 to 30°C (59 to 86°F)
  • do not use if carton is damaged or open
  • do not use if seal on tube is punctured or missing
    • see bottom of carton for lot number and expiration date
    • store at 15 to 30°C (59 to 86°F)
    • do not use if carton is damaged or open
    • do not use if seal on tube is punctured or missing

Inactive Ingredients

aloe barbadensis leaf juice, arginine, benzophenone-4, cetyl alcohol, dimethyl sulfoxide, melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol (and) caprylyl glycol (and) potassium sorbate (and) water (and) hexylene glycol, purified water, simmondsia chinensis (jojoba) seed oil, sodium polyacrylate, stearic acid

beeswax, cod liver oil (contains vitamin A & vitamin D), fragrance, mineral oil, microcrystalline wax

Questions Or Comments?

866-323-0107 or www.getskullduggery.com

866-323-0107 or www.getskullduggery.com

Otc - Purpose

Active ingredientsPurpose
Lanolin 15.5%Skin protectant
Petrolatum 53.4%Skin protectant

Do Not Use On

  • deep or puncture wounds
  • animal bites
  • serious burns

Direction

After procedure, apply A&D Ointment as needed to affected skin.

Principal Display Panel - Kit Carton

SKULLDUGGERY

NDC# 67234-047-01

For Temporary Pain
Relief associated
with Tattoos, Piercing,
and Hair Removal

1 TUBE (35g)
LIDOCAINE 4%
PAIN RELIEVING CREAM

NET WT. 1.25 Oz. (35g)

1 TUBE (35g)
A&D
OINTMENT SKIN PROTECTANT

NET WT. 1.25 Oz. (35g)

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)

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