FDA.reportPublic FDA data

Skullduggery Pain Relief and Skin Protection for Tattoos

Manufacturer
Natureplex, LLC | Natureplex LLC
Effective date
2017-04-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:33

Label at a glance#

ProductSkullduggery Pain Relief and Skin Protection for Tattoos
Active ingredientLanolin, Petrolatum, Lidocaine
Label structure19 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

LIDOCAINE 4%

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Pain Reliever

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes

Do not use

OTC - DO NOT USE SECTION

  • 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 SECTION

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

OTC - STOP USE SECTION

  • 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you develop a persistent rash
  • side effects occur, condition worsens, or
  • symptoms persist for more than 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

VITAMIN A&D

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Direction

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

This product
is manufactured
and distributed
by Natureplex™.

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1876729{1 (35000 MG) (lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical Ointment) / 1 (35000 MG) (lidocaine 40 MG/ML Topical Cream) } PackGPCK1
1876729{1 (35000 MG) (lanolin 15.5 % / petrolatum 53.4 % Topical Ointment)/ 1 (35000 MG) (lidocaine 4 % Topical Cream Topical Cream) } PackPSN1
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSN1
1421893lidocaine 4 % Topical CreamPSN1
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCD1
1421893lidocaine 40 MG/ML Topical CreamSCD1
1876729{1 (1.25 OZ) (lanolin 15.5 % / petrolatum 53.4 % Topical Ointment)/ 1 (1.25 OZ) (lidocaine 4 % Topical Cream Topical Cream) } PackSY1
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSY1
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSY1
1421893lidocaine 4 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67234-047-012025-01-30C16284748780-12cef2736-7877-d83d-e063-dadaa90ab31fSkullduggery Pain Relief and Skin Protection for Tattoos

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67234-047-01Skullduggery Pain Relief and Skin Protection for Tattoos1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-047SKULLDUGGERY PAIN RELIEF AND SKIN PROTECTION FOR TATTOOS (LANOLIN, PETROLATUM AND LIDOCAINE) KIT [NATUREPLEX, LLC]1Legacy NDC, 1 package rows20170411_d61ed5a0-c814-4822-9ea1-7244dedaa197.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67234-04767234-047-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
Lanolin7EV65EAW6HACTIB
Petrolatum4T6H12BN9UACTIB
YELLOW WAX2ZA36H0S2VIACT
COD LIVER OILBBL281NWFGIACT
LIGHT MINERAL OILN6K5787QVPIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
Lidocaine98PI200987ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
SULISOBENZONE1W6L629B4KIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ARGININE94ZLA3W45FIACT
WATER059QF0KO0RIACT
JOJOBA OIL724GKU717MIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
STEARIC ACID4ELV7Z65APIACT
TEA TREE OILVIF565UC2GIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1f92c347-487e-4a33-9014-53ae162a221dd61ed5a0-c814-4822-9ea1-7244dedaa1972017-04-10WarningsExact identifier
spl id: 1f92c347-487e-4a33-9014-53ae162a221d
spl set id: d61ed5a0-c814-4822-9ea1-7244dedaa197

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.