Label: SKULLDUGGERY PAIN RELIEF AND SKIN PROTECTION FOR TATTOOS- lanolin, petrolatum and lidocaine kit
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Contains inactivated NDC Code(s)
NDC Code(s): 67234-047-01 - Packager: Natureplex, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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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
- Directions
- Other information
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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?
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- Warnings
- Direction
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
SKULLDUGGERY PAIN RELIEF AND SKIN PROTECTION FOR TATTOOS
lanolin, petrolatum and lidocaine kitProduct 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, augmentedProduct 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 creamProduct 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)