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

Skullduggery Pain Relief and Skin Protection for Tattoos by

Drug Labeling and Warnings

Skullduggery Pain Relief and Skin Protection for Tattoos by is a Otc medication manufactured, distributed, or labeled by Natureplex, LLC, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• 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

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

SPL UNCLASSIFIED SECTION

VITAMIN A&D

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
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

• 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

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

Questions or comments?

866-323-0107 or www.getskullduggery.com

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

SKULLDUGGERY PAIN RELIEF AND SKIN PROTECTION FOR TATTOOS 
lanolin, petrolatum and lidocaine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67234-047

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67234-047-01	1 in 1 CARTON	06/04/2003

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	35 g
Part 2	1 TUBE	35 g

Part 1 of 2

A AND D 
lanolin and petrolatum ointment, augmented

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lanolin (UNII: 7EV65EAW6H) (Lanolin - UNII:7EV65EAW6H)	Lanolin	155 mg  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	534 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
COD LIVER OIL (UNII: BBL281NWFG)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		35 g in 1 TUBE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/04/2003

Part 2 of 2

LIDOCAINE PAIN RELIEVING 
lidocaine cream

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		35 g in 1 TUBE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/25/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/04/2003

Labeler - Natureplex, LLC (062808196)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(67234-047)