FDA Label for Skullduggery Pain Relief And Skin Protection For Tattoos
View Indications, Usage & Precautions
Skullduggery Pain Relief And Skin Protection For Tattoos Product Label
The following document was submitted to the FDA by the labeler of this product Natureplex, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
LIDOCAINE 4%
Drug Facts
VITAMIN A&D
Drug Facts
This product
is manufactured
and distributed
by Natureplex™.
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
Temporarily protects and helps relieve minor skin irritation due to tattooing, piercing, and hair removal
Warnings
For external use only.
Avoid contact with eyes
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
Otc - Ask Doctor
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
- you develop a persistent rash
- side effects occur, condition worsens, or
- symptoms persist for more than 7 days
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away: 800-222-1222.
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
- 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
beeswax, cod liver oil (contains vitamin A & vitamin D), fragrance, mineral oil, microcrystalline wax
Questions Or Comments?
866-323-0107 or www.getskullduggery.com
866-323-0107 or www.getskullduggery.com
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Lanolin 15.5% | Skin protectant |
| Petrolatum 53.4% | Skin protectant |
Do Not Use On
- deep or puncture wounds
- animal bites
- serious burns
Direction
After procedure, apply A&D Ointment as needed to affected skin.
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)
* Please review the disclaimer below.