SKULLDUGGERY PAIN RELIEF AND SKIN PROTECTION FOR TATTOOS- lanolin, petrolatum and lidocaine 
Natureplex, LLC

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.

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Skullduggery Pain Relief and Skin Protection for Tattoos

LIDOCAINE 4%

Drug Facts

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

Warnings

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

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

Stop use and ask a doctor if

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

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

Directions

Other information

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

Questions or comments?

866-323-0107 or www.getskullduggery.com

VITAMIN A&D

Drug Facts

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

Use

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

Warnings

For external use only.

Avoid contact with eyes

Stop use and ask a doctor if

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

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

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

Direction

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

Other information

Inactive ingredients

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

Questions or comments?

866-323-0107 or www.getskullduggery.com

This product
is manufactured
and distributed
by Natureplex™.

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
SKULLDUGGERY PAIN RELIEF AND SKIN PROTECTION FOR TATTOOS 
lanolin, petrolatum and lidocaine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-047
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67234-047-011 in 1 CARTON06/04/2003
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 35 g
Part 21 TUBE 35 g
Part 1 of 2
A AND D 
lanolin and petrolatum ointment, augmented
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lanolin (UNII: 7EV65EAW6H) (Lanolin - UNII:7EV65EAW6H) Lanolin155 mg  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum534 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
COD LIVER OIL (UNII: BBL281NWFG)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
135 g in 1 TUBE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/04/2003
Part 2 of 2
LIDOCAINE PAIN RELIEVING 
lidocaine cream
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SULISOBENZONE (UNII: 1W6L629B4K)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ARGININE (UNII: 94ZLA3W45F)  
WATER (UNII: 059QF0KO0R)  
JOJOBA OIL (UNII: 724GKU717M)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TEA TREE OIL (UNII: VIF565UC2G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
135 g in 1 TUBE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/25/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/04/2003
Labeler - Natureplex, LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(67234-047)

Revised: 4/2017
Document Id: 1f92c347-487e-4a33-9014-53ae162a221d
Set id: d61ed5a0-c814-4822-9ea1-7244dedaa197
Version: 1
Effective Time: 20170410
 
Natureplex, LLC