Label: PAINLESS TATTOO 1- benzocaine cream
- NDC Code(s): 54723-015-01
- Packager: Sambria Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 September 28, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
Avoid contact with eyes
Stop use and ask doctor ifcondition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.Discontinue use.
Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.
Protect this product from excessive heat and direact sun.
- KEEP OUT OF REACH OF CHILDREN
- Directions
-
Inactive ingredients
Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexyglycerin,
Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol,
Polyacrylamide, Propylene Glycol,StearicAcid, Triethanolamine. - Product label
-
INGREDIENTS AND APPEARANCE
PAINLESS TATTOO 1
benzocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54723-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z) EMU OIL (UNII: 344821WD61) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) LAURETH-7 (UNII: Z95S6G8201) TEA TREE OIL (UNII: VIF565UC2G) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54723-015-01 3 mL in 1 PACKET; Type 0: Not a Combination Product 09/26/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/26/2023 Labeler - Sambria Pharmaceuticals, LLC (078676259)