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

NDC Code(s): 67234-047-01
Packager: Natureplex, LLC

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 April 10, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

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)

Active ingredients	Purpose
Lanolin 15.5%	Skin protectant
Petrolatum 53.4%	Skin protectant

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

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

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

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

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

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

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

Part 2 of 2

LIDOCAINE PAIN RELIEVING
lidocaine cream

Product Information
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

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

Labeler - Natureplex, LLC (062808196)

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

View All Sections

	RxCUI	RxNorm NAME	RxTTY
1	664981	lanolin 15.5 % / petrolatum 53.4 % Topical Ointment	PSN
2	664981	lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical Ointment	SCD
3	664981	lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical Ointment	SY
4	664981	lanolin 15.5 % / petrolatum 53.4 % Topical Ointment	SY
5	1421893	lidocaine 4 % Topical Cream	PSN
6	1421893	lidocaine 40 MG/ML Topical Cream	SCD
7	1421893	lidocaine 4 % Topical Cream	SY
8	1876729	{1 (35000 MG) (lanolin 15.5 % / petrolatum 53.4 % Topical Ointment)/ 1 (35000 MG) (lidocaine 4 % Topical Cream Topical Cream) } Pack	PSN
9	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) } Pack	GPCK
10	1876729	{1 (1.25 OZ) (lanolin 15.5 % / petrolatum 53.4 % Topical Ointment)/ 1 (1.25 OZ) (lidocaine 4 % Topical Cream Topical Cream) } Pack	SY

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

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Stop use and ask a doctor if

Stop use and ask a doctor if

Stop use and ask a doctor if

Do not use on

Find additional resources

Safety

Related Resources

More Info on this Drug

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

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Stop use and ask a doctor if

Stop use and ask a doctor if

Stop use and ask a doctor if

Do not use on

Find additional resources

Safety

Related Resources

More Info on this Drug

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

Number of versions: 1

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

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

To receive this label RSS feed

To receive all DailyMed Updates for the last seven days

What will I get with the DailyMed RSS feed?

How to discontinue the RSS feed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

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

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.